Panels › Cardiovascular › Product code DRN · Class 2
Device, Counter-Pulsating, External
Regulation 870.5225
1510(k)s in 12 months (34 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiomedics, Inc. | 5 | 1 |
| Circulator Boot Corp. | 4 | 0 |
| Vasomedical, Inc. | 3 | 0 |
| External Counterpulsation Lab | 2 | 0 |
| Living Data Technologies Corporation | 2 | 0 |
| Nicore Equipment & Leasing, Inc. | 2 | 0 |
| Vamed Medical Instrument Co., Ltd. | 2 | 0 |
| Applied Cardiac Systems | 1 | 0 |
| Cardiassist Corp. | 1 | 0 |
| Chongqing Psk Sci-Tech Development Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2009 | Cardiomedics Incorporated Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000. Terminated |
DRN | K050172 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.