Panels › Cardiovascular › Product code MOP · Class 1
Rotator, Prosthetic Heart Valve
Regulation 870.3935
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MOP
| Company | 510(k)s | Recalls |
|---|---|---|
| Carbomedics, Inc. | 2 | 0 |
| Genzyme Surgical Product (Genzyme Biosurgery) | 1 | 0 |
| Sulzer Carbomedics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 1998 | K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE Genzyme Surgical Product (Genzyme Biosurgery) | MOP |
| Aug 4, 1998 | K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR Sulzer Carbomedics, Inc. | MOP |
| Apr 29, 1996 | K960923 | CARBOMEDICS MITRAL ROTATOR Carbomedics, Inc. | MOP |
| Jun 20, 1995 | K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR Carbomedics, Inc. | MOP |
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