Clearance Summary
MODIFICATION TO VIABAHN ENDOPROSTHESIS received FDA 510(k) clearance under submission number K023811, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-12-10.
- Submission: K023811
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3720
- Decision date: 2002-12-10
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.