Clearance Summary
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR received FDA 510(k) clearance under submission number K043342, sponsored by Gambro Renal Products. 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 2005-05-27.
- Submission: K043342
- Applicant / Sponsor: Gambro Renal Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2005-05-27
Classification & Regulation
This clearance is catalogued under FDA product code FJI and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.