510(k) K083470 ยท KRH Ring, Annuloplasty
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 23, 2009 |
| Received | Nov 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083470
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.