510(k) K001250

APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) by Asahi Medical Co., Ltd. — Product Code KDI

K001250 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)". The FDA issued a decision of Substantially Equivalent on August 16, 2000. 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.