Clearance Summary
K2 MEDICAL VASCULAR CLAMPS received FDA 510(k) clearance under submission number K120492, sponsored by K2 Medical 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 2012-04-30.
- Submission: K120492
- Applicant / Sponsor: K2 Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2012-04-30
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.