510(k) K152613 ยท OZT Balloon Aortic Valvuloplasty
True Flow Valvuloplasty Perfusion Catheter
| Applicant | C.R. Bard, Inc., Tempe AZ, US |
| Decision | Substantially Equivalent, Jan 19, 2016 |
| Received | Sep 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152613
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.