Clearance Summary
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H received FDA 510(k) clearance under submission number K980534, sponsored by The Heart Valve Div. Medtronic Cardiovascular Surg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-04-30.
- Submission: K980534
- Applicant / Sponsor: The Heart Valve Div. Medtronic Cardiovascular Surg
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 1998-04-30
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.