Imager™ II
145 catalogue numbers from M001316710, listed by Boston Scientific Corporation, United States, under Catheter, Intravascular, Diagnostic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
145catalogue numbers in this listing
20510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001316710 | 4 F Diameter | In distribution |
| M001316150 | 1.38 mm Diameter | In distribution |
| M001314070 | 1.70 mm Diameter | In distribution |
| M001314630 | 5 F Diameter | In distribution |
| M001314030 | 5 F Diameter | In distribution |
| M001314680 | 5 F Diameter | In distribution |
| M001315070 | 5 F Diameter | In distribution |
| M001314350 | 5 F Diameter | In distribution |
| M001315320 | 1.70 mm Diameter | In distribution |
| M001314340 | 1.70 mm Diameter | In distribution |
| M001314670 | 5 F Diameter | In distribution |
| M001316190 | 1.38 mm Diameter | In distribution |
| M001314810 | 1.70 mm Diameter | In distribution |
| M001314870 | 5 F Diameter | In distribution |
| M001314660 | 1.70 mm Diameter | In distribution |
| M001315190 | 1.70 mm Diameter | In distribution |
| M001314880 | 5 F Diameter | In distribution |
| M001316770 | 4 F Diameter | In distribution |
| M001315260 | 4 F Diameter | In distribution |
| M001316330 | 1.38 mm Diameter | In distribution |
| M001314010 | 5 F Diameter | In distribution |
| M001314120 | 5 F Diameter | In distribution |
| M001314210 | 5 F Diameter | In distribution |
| M001314690 | 1.70 mm Diameter | In distribution |
| M001314130 | 5 F Diameter | In distribution |
| M001316090 | 4 F Diameter | In distribution |
| M001314110 | 5 F Diameter | In distribution |
| M001315080 | 1.70 mm Diameter | In distribution |
| M001314580 | 5 F Diameter | In distribution |
| M001316120 | 4 F Diameter | In distribution |
| M001315210 | 5 F Diameter | In distribution |
| M001314620 | 5 F Diameter | In distribution |
| M001314040 | 1.70 mm Diameter | In distribution |
| M001314910 | 5 F Diameter | In distribution |
| M001314440 | 5 F Diameter | In distribution |
| M001314260 | 5 F Diameter | In distribution |
| M001315310 | 1.70 mm Diameter | In distribution |
| M001314170 | 1.70 mm Diameter | In distribution |
| M001314250 | 1.70 mm Diameter | In distribution |
| M001316370 | 1.38 mm Diameter | In distribution |
| M001314770 | 1.70 mm Diameter | In distribution |
| M001314360 | 5 F Diameter | In distribution |
| M001314050 | 1.70 mm Diameter | In distribution |
| M001316440 | 1.38 mm Diameter | In distribution |
| M001314400 | 1.70 mm Diameter | In distribution |
| M001315170 | 5 F Diameter | In distribution |
| M001315250 | 4 F Diameter | In distribution |
| M001315000 | 1.38 mm Diameter | In distribution |
| M001314090 | 5 F Diameter | In distribution |
| M001315060 | 5 F Diameter | In distribution |
| M001315100 | 1.38 mm Diameter | In distribution |
| M001316750 | 1.38 mm Diameter | In distribution |
| M001315050 | 5 F Diameter | In distribution |
| M001314890 | 1.70 mm Diameter | In distribution |
| M001314220 | 5 F Diameter | In distribution |
| M001314650 | 5 F Diameter | In distribution |
| M001314820 | 1.70 mm Diameter | In distribution |
| M001316670 | 1.38 mm Diameter | In distribution |
| M001315020 | 1.38 mm Diameter | In distribution |
| M001315180 | 1.70 mm Diameter | In distribution |
| M001314860 | 5 F Diameter | In distribution |
| M001316870 | 4 F Diameter | In distribution |
| M001315160 | 5 F Diameter | In distribution |
| M001314460 | 1.70 mm Diameter | In distribution |
| M001314230 | 1.70 mm Diameter | In distribution |
| M001315220 | 5 F Diameter | In distribution |
| M001314840 | 1.70 mm Diameter | In distribution |
| M001314270 | 1.70 mm Diameter | In distribution |
| M001315240 | 5 F Diameter | In distribution |
| M001315280 | 5 F Diameter | In distribution |
| M001316030 | 1.38 mm Diameter | In distribution |
| M001316690 | 1.38 mm Diameter | In distribution |
| M001316230 | 1.38 mm Diameter | In distribution |
| M001314590 | 5 F Diameter | In distribution |
| M001314520 | 5 F Diameter | In distribution |
| M001316130 | 1.38 mm Diameter | In distribution |
| M001314100 | 5 F Diameter | In distribution |
| M001315140 | 1.70 mm Diameter | In distribution |
| M001314850 | 1.70 mm Diameter | In distribution |
| M001314150 | 1.70 mm Diameter | In distribution |
| M001314080 | 1.70 mm Diameter | In distribution |
| M001315110 | 1.38 mm Diameter | In distribution |
| M001314000 | 1.70 mm Diameter | In distribution |
| M001315010 | 4 F Diameter | In distribution |
| M001314430 | 5 F Diameter | In distribution |
| M001314530 | 5 F Diameter | In distribution |
| M001315150 | 5 F Diameter | In distribution |
| M001316350 | 1.38 mm Diameter | In distribution |
| M001316830 | 4 F Diameter | In distribution |
| M001314700 | 5 F Diameter | In distribution |
| M001316790 | 4 F Diameter | In distribution |
| M001316630 | 1.38 mm Diameter | In distribution |
| M001315230 | 1.70 mm Diameter | In distribution |
| M001314190 | 5 F Diameter | In distribution |
| M001314480 | 5 F Diameter | In distribution |
| M001316310 | 1.38 mm Diameter | In distribution |
| M001314370 | 1.70 mm Diameter | In distribution |
| M001314410 | 1.70 mm Diameter | In distribution |
| M001314790 | 5 F Diameter | In distribution |
| M001316890 | 4 F Diameter | In distribution |
| M001314140 | 5 F Diameter | In distribution |
| M001315270 | 1.38 mm Diameter | In distribution |
| M001314310 | 1.70 mm Diameter | In distribution |
| M001316810 | 1.38 mm Diameter | In distribution |
| M001316850 | 4 F Diameter | In distribution |
| M001314570 | 1.70 mm Diameter | In distribution |
| M001314180 | 1.70 mm Diameter | In distribution |
| M001314160 | 1.70 mm Diameter | In distribution |
| M001315130 | 5 F Diameter | In distribution |
| M001316250 | 1.38 mm Diameter | In distribution |
| M001316040 | 1.38 mm Diameter | In distribution |
| M001314710 | 1.70 mm Diameter | In distribution |
| M001314330 | 1.70 mm Diameter | In distribution |
| M001315300 | 1.70 mm Diameter | In distribution |
| M001316060 | 4 F Diameter | In distribution |
| M001314320 | 5 F Diameter | In distribution |
| M001314780 | 5 F Diameter | In distribution |
| M001315040 | 5 F Diameter | In distribution |
| M001314540 | 1.70 mm Diameter | In distribution |
| M001315200 | 1.70 mm Diameter | In distribution |
| M001314760 | 5 F Diameter | In distribution |
| M001314550 | 5 F Diameter | In distribution |
| M001314420 | 1.70 mm Diameter | In distribution |
| M001315330 | 5 F Diameter | In distribution |
| M001314640 | 1.70 mm Diameter | In distribution |
| M001314060 | 1.70 mm Diameter | In distribution |
| M001316070 | 1.38 mm Diameter | In distribution |
| M001314300 | 5 F Diameter | In distribution |
| M001314830 | 5 F Diameter | In distribution |
| M001315120 | 4 F Diameter | In distribution |
| M001314390 | 5 F Diameter | In distribution |
| M001314470 | 1.70 mm Diameter | In distribution |
| M001314800 | 1.70 mm Diameter | In distribution |
| M001314500 | 1.70 mm Diameter | In distribution |
| M001314020 | 1.70 mm Diameter | In distribution |
| M001315090 | 1.38 mm Diameter | In distribution |
| M001314750 | 1.70 mm Diameter | In distribution |
| M001314900 | 5 F Diameter | In distribution |
| M001315030 | 1.70 mm Diameter | In distribution |
| M001314240 | 5 F Diameter | In distribution |
| M001314450 | 1.70 mm Diameter | In distribution |
| M001314560 | 1.70 mm Diameter | In distribution |
| M001316020 | 4 F Diameter | In distribution |
| M001315290 | 1.70 mm Diameter | In distribution |
| M001316580 | 4 F Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152605 | 2015-10-29 |
| K121694 | 2012-09-14 |
| K120495 | 2012-05-21 |
| K120893 | 2012-03-29 |
| K063312 | 2006-11-30 |
| K060175 | 2006-03-24 |
| K050863 | 2005-09-02 |
| K050684 | 2005-05-20 |
| K050577 | 2005-03-30 |
| K040776 | 2004-04-29 |
| K023681 | 2002-11-26 |
| K022621 | 2002-09-04 |
| K970207 | 1997-07-31 |
| K971607 | 1997-07-24 |
| K953114 | 1995-09-12 |
| K942927 | 1995-06-13 |
| K913871 | 1991-11-25 |
| K904788 | 1990-12-17 |
| K895542 | 1990-04-06 |
| K891580 | 1989-08-03 |
Recalls
40 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 37252 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 263522 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 615 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 8715 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1669 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 385 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 363 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 230 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 3127 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1015 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 120 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 86898 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 105 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 11109 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 16797 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 8579 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 0 |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1322 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1065 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 116091 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 297479 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1465 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 15270 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 290 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 15 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 46860 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1170 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 5510 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 10 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 4715 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 2314 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 4942 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 4270 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 1950 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 25617 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 440 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 9271 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 8575 catheters |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 0 |
| 2024-03-21 | Class I | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the cathet | 330 catheters |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.