510(k) K013418

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY by Asahi Medical Co., Ltd. — Product Code KDI

K013418 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY". The FDA issued a decision of Substantially Equivalent on July 9, 2002. 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.