Clearance Summary
CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI received FDA 510(k) clearance under submission number K832124, sponsored by Med-West, 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 1983-08-12.
- Submission: K832124
- Applicant / Sponsor: Med-West, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.