Panels › Cardiovascular › Product code DWZ · Class 2
Device, Biopsy, Endomyocardial
Regulation 870.4075
0510(k)s in 12 months (23 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DWZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis Corp. | 5 | 0 |
| Annex Medical, Inc. | 2 | 0 |
| Boston Scientific Corp | 2 | 0 |
| Fehling Instruments GmbH | 2 | 0 |
| Heartport, Inc. | 1 | 1 |
| Portlyn Corp. | 2 | 0 |
| Atc Technologies, Inc. | 1 | 0 |
| CIVCO Medical Instruments Co., Inc. | 1 | 0 |
| Cook, Inc. | 1 | 0 |
| Dlp, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2005 | Heartport, Inc. The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Terminated |
DWZ | K974175 |
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