Clearance Summary
CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD (2.0 TO 4.0 MM OUTER DIAMETER VESSELS), M received FDA 510(k) clearance under submission number K011589, sponsored by Bypass , Ltd.. 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 2001-12-26.
- Submission: K011589
- Applicant / Sponsor: Bypass , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2001-12-26
Classification & Regulation
This clearance is catalogued under FDA product code NCA and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.