Clearance Summary
VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET received FDA 510(k) clearance under submission number K870556, 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 1987-03-10.
- Submission: K870556
- Applicant / Sponsor: Van-Tec, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1987-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KOB and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.