510(k) K041726

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX by Asahi Medical Co., Ltd. — Product Code KDI

K041726 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX". The FDA issued a decision of Substantially Equivalent on July 23, 2004. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Asahi Medical Co., Ltd. has at least 10 other 510(k) clearances on record.