510(k) K020864 ยท KRH Ring, Annuloplasty
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Mar 18, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020864
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.