Clearance Summary
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM received FDA 510(k) clearance under submission number K012883, sponsored by Boston Scientific Corp. 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 2001-10-12.
- Submission: K012883
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2001-10-12
Classification & Regulation
This clearance is catalogued under FDA product code ESW and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.