510(k) K121083 ยท OZT Balloon Aortic Valvuloplasty
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
| Applicant | Loma Vista Medical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | Apr 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2013 | Loma Vista Medical TRUE Dilatation Balloon Valvuloplasty Catheter,
REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes:
20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm;
Intended to be used for Terminated |
OZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.