Clearance Summary
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 received FDA 510(k) clearance under submission number K992592, sponsored by A-Med Systems, 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 2000-05-04.
- Submission: K992592
- Applicant / Sponsor: A-Med Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 2000-05-04
Classification & Regulation
This clearance is catalogued under FDA product code KFM and 21 CFR 870.4360, within the Cardiovascular review panel as a Class II device.