Company ยท US
Cardiomedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2005. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRN | Device, Counter-Pulsating, External | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2005 | K050172 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 Cardiomedics, Inc. | DRN |
| Jan 7, 2003 | K023427 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 Cardiomedics, Inc. | DRN |
| Aug 8, 2002 | K022107 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 Cardiomedics, Inc. | DRN |
| Feb 28, 2001 | K010261 | CARDIOMEDICS ECP SYSTEM Cardiomedics, Inc. | DRN |
| Sep 18, 1987 | K872034 | CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM Cardiomedics, Inc. | DRN |
Latest recalls
| 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 |