Clearance Summary
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG received FDA 510(k) clearance under submission number K050111, 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 2005-03-08.
- Submission: K050111
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4400
- Decision date: 2005-03-08
Classification & Regulation
This clearance is catalogued under FDA product code DTN and 21 CFR 870.4400, within the Cardiovascular review panel as a Class II device.