510(k) K150343 ยท OZT Balloon Aortic Valvuloplasty
V8 Transluminal BAV Catheter
| Applicant | Intervalve, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 3, 2015 |
| Received | Feb 11, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150343
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.