Clearance Summary
LABELING CHANGE - VIASPAN(TM) (BELZER UW) received FDA 510(k) clearance under submission number K900492, sponsored by The DU Pont Co.. 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 1990-03-20.
- Submission: K900492
- Applicant / Sponsor: The DU Pont Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 1990-03-20
Classification & Regulation
This clearance is catalogued under FDA product code KDL and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.