Clearance Summary
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE received FDA 510(k) clearance under submission number K040255, sponsored by Gambro Renal Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-05-24.
- Submission: K040255
- Applicant / Sponsor: Gambro Renal Products, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2004-05-24
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.