Clearance Summary
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME received FDA 510(k) clearance under submission number K001927, sponsored by Thoratec Laboratories Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-12-18.
- Submission: K001927
- Applicant / Sponsor: Thoratec Laboratories Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2000-12-18
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.