Clearance Summary
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 received FDA 510(k) clearance under submission number K992056, 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 1999-10-12.
- Submission: K992056
- Applicant / Sponsor: Sulzer Carbomedics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 1999-10-12
Classification & Regulation
This clearance is catalogued under FDA product code KRH and 21 CFR 870.3800, within the Cardiovascular review panel as a Class II device.