510(k) K050172 ยท DRN Device, Counter-Pulsating, External
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000
| Applicant | Cardiomedics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 31, 2005 |
| Received | Jan 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050172
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.