The following data is part of a premarket notification filed by Sulzer Carbomedics, Inc. with the FDA for Sulzer Carbomedics Low Profile Mitral Rotator.
| Device ID | K974648 |
| 510k Number | K974648 |
| Device Name: | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR |
| Classification | Rotator, Prosthetic Heart Valve |
| Applicant | SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton SULZER CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | MOP |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-08-04 |
| Summary: | summary |