510(k) K123111 ยท OZT Balloon Aortic Valvuloplasty
V8 TRANSLUMINAL BAV CATHETER
| Applicant | Intervalve, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 31, 2013 |
| Received | Oct 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123111
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.