510(k) K133569 ยท OZT Balloon Aortic Valvuloplasty
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
| Applicant | Bard Peripheral Vascular, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Nov 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133569
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.