Clearance Summary
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM received FDA 510(k) clearance under submission number K000001, sponsored by Boston Scientific Scimed, 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 2000-06-05.
- Submission: K000001
- Applicant / Sponsor: Boston Scientific Scimed, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3720
- Decision date: 2000-06-05
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.