Clearance Summary
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 received FDA 510(k) clearance under submission number K994208, sponsored by Medtronic Perfusion Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-01-13.
- Submission: K994208
- Applicant / Sponsor: Medtronic Perfusion Systems
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4260
- Decision date: 2000-01-13
Classification & Regulation
This clearance is catalogued under FDA product code DTM and 21 CFR 870.4260, within the Cardiovascular review panel as a Class II device.