Clearance Summary
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE received FDA 510(k) clearance under submission number K001440, sponsored by Genzyme Surgical Product (Genzyme Biosurgery). The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2000-11-13.
- Submission: K001440
- Applicant / Sponsor: Genzyme Surgical Product (Genzyme Biosurgery)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2000-11-13
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.