Clearance Summary
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM received FDA 510(k) clearance under submission number K012763, sponsored by Cobe Cardiovascular, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-11-15.
- Submission: K012763
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2001-11-15
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.