Clearance Summary
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER received FDA 510(k) clearance under submission number K850139, sponsored by Rapid Diagnostic Laboratories, 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 1985-04-10.
- Submission: K850139
- Applicant / Sponsor: Rapid Diagnostic Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4280
- Decision date: 1985-04-10
Classification & Regulation
This clearance is catalogued under FDA product code KRJ and 21 CFR 870.4280, within the Cardiovascular review panel as a Class II device.