Clearance Summary
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT received FDA 510(k) clearance under submission number K012952, sponsored by Boston Scientific/Medi-Tech. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-10-02.
- Submission: K012952
- Applicant / Sponsor: Boston Scientific/Medi-Tech
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2001-10-02
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.