EZ-Pak™ Kit
Cath 6A0073 SS 5PK6F EZ W/3DRC XT.035INP
11manufacturers in China registered for this device type
39catalogue 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 | 2016-07-03 |
| Record revised | 2019-01-15 (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 |
| Sizes | Catheter gauge 5 to 7 Fr |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6A0073 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0101 | Catheter Gauge 6.0 Fr | In distribution |
| 5A0093 | Catheter Gauge 5.0 Fr | In distribution |
| 858445 | Catheter Gauge 6.0 Fr | In distribution |
| 5A0092 | Catheter Gauge 5.0 Fr | In distribution |
| 5A0065 | Catheter Gauge 5.0 Fr | In distribution |
| 558443 | Catheter Gauge 6.0 Fr | In distribution |
| 5A0066 | Catheter Gauge 5.0 Fr | In distribution |
| 5A0067 | Catheter Gauge 5.0 Fr | In distribution |
| 6A0068 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0067 | Catheter Gauge 6.0 Fr | In distribution |
| 558445 | Catheter Gauge 6.0 Fr | In distribution |
| 558447 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0104 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0106 | Catheter Gauge 6.0 Fr | In distribution |
| 6A0066 | Catheter Gauge 6.0 Fr | In distribution |
| 858418 | Catheter Gauge 6.0 Fr | In distribution |
| 858420 | Catheter Gauge 6.0 Fr | In distribution |
| 384902 | Catheter Gauge 7.0 Fr | Withdrawn |
| 358484 | Catheter Gauge 6.0 Fr | Withdrawn |
| 388420 | Catheter Gauge 6.0 Fr | Withdrawn |
| 558419 | Catheter Gauge 6.0 Fr | Withdrawn |
| 554902 | Catheter Gauge 7.0 Fr | Withdrawn |
| 558418 | Catheter Gauge 6.0 Fr | Withdrawn |
| 6A0107 | Catheter Gauge 6.0 Fr | Withdrawn |
| 558453 | Catheter Gauge 7.0 Fr | Withdrawn |
| 558448 | Catheter Gauge 6.0 Fr | Withdrawn |
| 858448 | Catheter Gauge 6.0 Fr | Withdrawn |
| 858443 | Catheter Gauge 6.0 Fr | Withdrawn |
| 6A0100 | Catheter Gauge 6.0 Fr | Withdrawn |
| 388410 | Catheter Gauge 6.0 Fr | Withdrawn |
| 558450 | Catheter Gauge 7.0 Fr | Withdrawn |
| 6A0105 | Catheter Gauge 6.0 Fr | Withdrawn |
| 558420 | Catheter Gauge 6.0 Fr | Withdrawn |
| 858419 | Catheter Gauge 6.0 Fr | Withdrawn |
| 5A0073 | Catheter Gauge 5.0 Fr | Withdrawn |
| 858447 | Catheter Gauge 6.0 Fr | Withdrawn |
| 350010 | Catheter Gauge 7.0 Fr | Withdrawn |
| 558500 | 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.