Clearance Summary
P-S BERLIN VESSEL CLAMP received FDA 510(k) clearance under submission number K820949, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1982-04-29.
- Submission: K820949
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1982-04-29
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.