510(k) K083623 ยท KRH Ring, Annuloplasty
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Dec 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083623
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.