Clearance Summary
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR received FDA 510(k) clearance under submission number K974648, sponsored by Sulzer Carbomedics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-08-04.
- Submission: K974648
- Applicant / Sponsor: Sulzer Carbomedics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3935
- Decision date: 1998-08-04
Classification & Regulation
This clearance is catalogued under FDA product code MOP and 21 CFR 870.3935, within the Cardiovascular review panel as a Class I device.