Clearance Summary
EXEL A-V FISTULA SET received FDA 510(k) clearance under submission number K903945, sponsored by Exel Intl.. 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 1990-11-20.
- Submission: K903945
- Applicant / Sponsor: Exel Intl.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1990-11-20
Classification & Regulation
This clearance is catalogued under FDA product code FIE and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.