Clearance Summary
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS received FDA 510(k) clearance under submission number K964043, sponsored by Cobe Cardiovascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-09-29.
- Submission: K964043
- Applicant / Sponsor: Cobe Cardiovascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 1997-09-29
Classification & Regulation
This clearance is catalogued under FDA product code DTZ and 21 CFR 870.4350, within the Cardiovascular review panel as a Class II device.