Clearance Summary
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H received FDA 510(k) clearance under submission number K013393, sponsored by A-Med Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-11-09.
- Submission: K013393
- Applicant / Sponsor: A-Med Systems, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 2001-11-09
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.