510(k) K152150 ยท OZT Balloon Aortic Valvuloplasty
V8 Balloon Aortic Valvuloplasty Catheter
| Applicant | Intervalve, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | Aug 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152150
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.