Clearance Summary
RADAR VASCULAR COMPRESSION DEVICE received FDA 510(k) clearance under submission number K142122, sponsored by Advanced Vascular Dynamics. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-12-04.
- Submission: K142122
- Applicant / Sponsor: Advanced Vascular Dynamics
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2014-12-04
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.