510(k) K142199 ยท OZT Balloon Aortic Valvuloplasty
Ascendra Balloon Aortic Valvaloplasty Catheter
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 29, 2014 |
| Received | Aug 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142199
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.