Clearance Summary
VASORING* VRC VASCULAR RING CONNECTOR received FDA 510(k) clearance under submission number K061626, sponsored by Sunwei Tech Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-10-05.
- Submission: K061626
- Applicant / Sponsor: Sunwei Tech Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2006-10-05
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.