Clearance Summary
CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS received FDA 510(k) clearance under submission number K902475, sponsored by Cardio-Pak. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-12-03.
- Submission: K902475
- Applicant / Sponsor: Cardio-Pak
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1990-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.