Clearance Summary
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX received FDA 510(k) clearance under submission number K122612, sponsored by Maquet Cardiovascular, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-09-10.
- Submission: K122612
- Applicant / Sponsor: Maquet Cardiovascular, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2012-09-10
Classification & Regulation
This clearance is catalogued under FDA product code MAL and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.