Panels › Cardiovascular › Product code OZT · Class 2
Balloon Aortic Valvuloplasty
Regulation 870.1255
2510(k)s in 12 months (22 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Intervalve, Inc. | 5 | 1 |
| C.R. Bard, Inc. | 5 | 0 |
| Dongguan TT Medical, Inc. | 3 | 0 |
| Edwards Lifesciences | 2 | 0 |
| Loma Vista Medical | 1 | 1 |
| NuMED, Inc. | 2 | 0 |
| Bard Peripheral Vascular, Inc. | 1 | 0 |
| Disa Medinotec | 1 | 0 |
| Intervention Tech, Inc. ; dba Corvention | 1 | 0 |
| Toray Industries, Inc. | 1 | 0 |
| 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 | K133607 |
| 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 | K121083 |
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