MOP — Rotator, Prosthetic Heart Valve Class I
FDA product code MOP covers "Rotator, Prosthetic Heart Valve", a Class I medical device regulated under 21 CFR 870.3935. Submissions are reviewed by the Cardiovascular panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOP
- Device Class
- Class I
- Regulation Number
- 870.3935
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K980016 | genzyme surgical product (genzyme biosurgery) | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | August 7, 1998 |
| K974648 | sulzer carbomedics | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | August 4, 1998 |
| K960923 | carbomedics | CARBOMEDICS MITRAL ROTATOR | April 29, 1996 |
| K951368 | carbomedics | CARBOMEDICS EXENDED MITRAL ROTATOR | June 20, 1995 |