Panels › Cardiovascular › Product code DWP · Class 2
Dilator, Vessel, Surgical
Regulation 870.4475
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DWP
| Company | 510(k)s | Recalls |
|---|---|---|
| American Edwards Laboratories | 3 | 0 |
| Baxter Healthcare Corp | 1 | 1 |
| Bio-Vascular, Inc. | 2 | 0 |
| Shiley, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Cimed Intl., Inc. | 1 | 0 |
| Fehling Surgical Instruments, Inc. | 1 | 0 |
| Fetzer Medical GmbH & Co. KG | 1 | 0 |
| Geister Medizin Technik GmbH | 1 | 0 |
| Geomed Medizin-Technik GmbH & Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Vascular Probe, Product Codes:
a) 7081015: 8CM, 1- 1.5 MM GLOBAL,
b) 7081520: 8CM, 1.5-2 MM GLOBAL,
c) 7082025: 8CM, 2-2.5 MM GLOBAL,
d) 7151015: 15CM, 1-1.5 MM GLOBAL,
e) 7151520 Open, Classified |
DWP | K130896 |
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