Clearance Summary
HEMOFILTRATION CATHETER HF-100 received FDA 510(k) clearance under submission number K840322, sponsored by Vas-Cath of Canada , Ltd.. 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 1984-04-24.
- Submission: K840322
- Applicant / Sponsor: Vas-Cath of Canada , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 1984-04-24
Classification & Regulation
This clearance is catalogued under FDA product code FIQ and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.