510(k) K133607 ยท OZT Balloon Aortic Valvuloplasty
V8 TRANSLUMINAL BAV CATHETER
| Applicant | Intervalve, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 11, 2014 |
| Received | Nov 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2014 | InterValve Inc InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. Terminated |
OZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.