510(k) K132728 ยท OZT Balloon Aortic Valvuloplasty
V8 TRANSLUMINAL BAV CATHETER
| Applicant | Intervalve, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Sep 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132728
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.