510(k) K001734 ยท MGZ Valvulotome
FOGARTY VALVULOTOME, MODEL 700091
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 26, 2001 |
| Received | Jun 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001734
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.