Clearance Summary
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT received FDA 510(k) clearance under submission number K880041, sponsored by D-R Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-06-10.
- Submission: K880041
- Applicant / Sponsor: D-R Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 1988-06-10
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.