Rotator, Prosthetic Heart Valve
FDA product code MOP · Class I (low risk) · 21 CFR 870.3935 · Cardiovascular
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980016 | Millennium Valve Introducer/Rotator HandleMOP · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 08/07/1998SE |
| K974648 | Sulzer Carbomedics Low Profile Mitral RotatorMOP · Traditional | Sulzer Carbomedics, Inc. | 08/04/1998SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 04/29/1996SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 06/20/1995SE |