Clearance Summary
CARDIO-COOL received FDA 510(k) clearance under submission number K860523, sponsored by Bio-Vascular, 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 1986-04-29.
- Submission: K860523
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 1986-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.