Clearance Summary
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) received FDA 510(k) clearance under submission number K140561, sponsored by Xlumena, Inc.. 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 2014-04-23.
- Submission: K140561
- Applicant / Sponsor: Xlumena, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5015
- Decision date: 2014-04-23
Classification & Regulation
This clearance is catalogued under FDA product code PCU and 21 CFR 876.5015, within the Gastroenterology, Urology review panel as a Class II device.