Catheter, Intravascular, Diagnostic
Cath 038445 PF 5PK KIT6F ST XT Angio KIT
11manufacturers in China registered for this device type
38catalogue numbers in this listing
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 | Medtronic, Inc., 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, Manufacturer, Exporter |
| 510(k) | K932092 |
| Record published | 2016-06-06 |
| Record revised | 2019-01-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store catheters in a cool, dry area. |
| Packaging | Pack of 5, pack of 10 |
| Sizes | Catheter gauge 4 to 7 Fr; length 125 cm; lumen/inner diameter 1.295 mm |
| Distribution end date | 2020-04-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 038443 | Catheter Gauge 6.0 Fr | In distribution |
| 038445 | Catheter Gauge 6.0 Fr | In distribution |
| 038457 | Catheter Gauge 6.0 Fr | In distribution |
| 038448 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0072 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0103 | Catheter Gauge 6.0 Fr | In distribution |
| 038442 | Catheter Gauge 6.0 Fr | In distribution |
| 008420 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0063 | Catheter Gauge 6.0 Fr | In distribution |
| 5A0064 | Catheter Gauge 5.0 Fr | In distribution |
| 5A0062 | Catheter Gauge 5.0 Fr | In distribution |
| 018418 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0102 | Catheter Gauge 6.0 Fr | In distribution |
| 5B0013 | Catheter Gauge 5.0 Fr | In distribution |
| 4A0063 | Catheter Gauge 4.0 Fr | In distribution |
| 4A0069 | Catheter Gauge 4.0 Fr | In distribution |
| 5A0072 | Catheter Gauge 5.0 Fr | In distribution |
| 5A0063 | Catheter Gauge 5.0 Fr | In distribution |
| 6A0064 | Catheter Gauge 6.0 Fr | In distribution |
| 4A0062 | Catheter Gauge 4.0 Fr | In distribution |
| 6B0007 | Catheter Gauge 6.0 Fr | Withdrawn |
| 038467 | Catheter Gauge 6.0 Fr | Withdrawn |
| 4B0002 | Catheter Gauge 4.0 Fr | Withdrawn |
| 6A0065 | Catheter Gauge 6.0 Fr | Withdrawn |
| 218445 | Catheter Gauge 6.0 Fr | Withdrawn |
| 008419 | Catheter Gauge 6.0 Fr | Withdrawn |
| 5A0095 | Catheter Gauge 5.0 Fr | Withdrawn |
| 038019 | Catheter Gauge 6.0 Fr | Withdrawn |
| 4B0001 | Catheter Gauge 4.0 Fr | Withdrawn |
| 001372 | Length 125.0 cm | Withdrawn |
| 014903 | Catheter Gauge 7.0 Fr | Withdrawn |
| 6A0108 | Catheter Gauge 6.0 Fr | Withdrawn |
| 4A0076 | Catheter Gauge 4.0 Fr | Withdrawn |
| 001372 | Catheter Gauge 7.0 Fr | Withdrawn |
| 6A0137 | Catheter Gauge 6.0 Fr | Withdrawn |
| 4A0061 | Catheter Gauge 4.0 Fr | Withdrawn |
| 250026 | Catheter Gauge 6.0 Fr | Withdrawn |
| 038465 | Catheter Gauge 6.0 Fr | Withdrawn |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2004-01-14 | Not classified | Other | Catheter distal tip may separate | 20 units | 2004-11-15 |
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.