Clearance Summary
GORE HYBRID VASCULAR GRAFT received FDA 510(k) clearance under submission number K093934, sponsored by W.L. Gore & Associates. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-03-17.
- Submission: K093934
- Applicant / Sponsor: W.L. Gore & Associates
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2010-03-17
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.