MOP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rotator, Prosthetic Heart Valve
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 |
| SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648) | Sulzer Carbomedics, Inc. | 1998-08-04 |
| CARBOMEDICS MITRAL ROTATOR (K960923) | Carbomedics, Inc. | 1996-04-29 |
| CARBOMEDICS EXENDED MITRAL ROTATOR (K951368) | Carbomedics, Inc. | 1995-06-20 |
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Every clearance here is in the API, with alerts when new ones post.