510(k) K140241 ยท OZT Balloon Aortic Valvuloplasty
EDWARDS TRANSFEMORAL BALLOON CATHETER
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 3, 2014 |
| Received | Jan 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140241
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.