Clearance Summary
VIABAHN ENDOPROSTHESIS received FDA 510(k) clearance under submission number K013648, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-01-08.
- Submission: K013648
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3720
- Decision date: 2002-01-08
Classification & Regulation
This clearance is catalogued under FDA product code JCT and 21 CFR 878.3720, within the General, Plastic Surgery review panel as a Class II device.