Clearance Summary
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT received FDA 510(k) clearance under submission number K102596, sponsored by Atrium Medical Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-10-05.
- Submission: K102596
- Applicant / Sponsor: Atrium Medical Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2010-10-05
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.