Clearance Summary
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 received FDA 510(k) clearance under submission number K001138, sponsored by Medtronic Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-04-27.
- Submission: K001138
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4260
- Decision date: 2000-04-27
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.