Clearance Summary
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM received FDA 510(k) clearance under submission number K011881, sponsored by Guidant Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-07-18.
- Submission: K011881
- Applicant / Sponsor: Guidant Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 2001-07-18
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.