Clearance Summary
OCCLUSION CLAMP** DEVICE received FDA 510(k) clearance under submission number K964251, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-05-23.
- Submission: K964251
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1997-05-23
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.