Clearance Summary
DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H received FDA 510(k) clearance under submission number K893678, sponsored by Medtronic Blood Systems, 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 1989-11-27.
- Submission: K893678
- Applicant / Sponsor: Medtronic Blood Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3800
- Decision date: 1989-11-27
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.