Clearance Summary
ATRAUMATIC VASCULAR CLAMPS received FDA 510(k) clearance under submission number K102048, sponsored by Geomed Medizin-Technik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-11-09.
- Submission: K102048
- Applicant / Sponsor: Geomed Medizin-Technik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2010-11-09
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.