510(k) K914020

MODIFIED ASAHI PAN-SERIES HEMOFILTERS by Asahi Medical Co., Ltd. — Product Code KDI

K914020 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "MODIFIED ASAHI PAN-SERIES HEMOFILTERS". The FDA issued a decision of Substantially Equivalent on March 20, 1992. 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.