Clearance Summary
VAN-TEC GUIDE WIRE W/HYDROMER COATING received FDA 510(k) clearance under submission number K851160, 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 1985-07-29.
- Submission: K851160
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1985-07-29
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.