510(k) K023427 ยท DRN Device, Counter-Pulsating, External
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
| Applicant | Cardiomedics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 7, 2003 |
| Received | Oct 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023427
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.