510(k) K083191 ยท KRH Ring, Annuloplasty
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 10, 2009 |
| Received | Oct 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083191
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.