Clearance Summary
MARDIS DANGLER URETERAL STENT SET received FDA 510(k) clearance under submission number K860267, sponsored by Van-Tec, Inc.. 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 1986-04-03.
- Submission: K860267
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 1986-04-03
Classification & Regulation
This clearance is catalogued under FDA product code FAD and 21 CFR 876.4620, within the Gastroenterology, Urology review panel as a Class II device.