Clearance Summary
WHOLEY OCCLUSION BALLOON CATHETER received FDA 510(k) clearance under submission number K772011, sponsored by Cook, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1979-06-15.
- Submission: K772011
- Applicant / Sponsor: Cook, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1979-06-15
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.