Clearance Summary
NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER received FDA 510(k) clearance under submission number K002133, sponsored by Boston Scientific Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-10-12.
- Submission: K002133
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2000-10-12
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.