510(k) K945596

ALTRES(R) 140 HEMODIALYZER by Althin Medical AB an Affiliate of Baxter Intl — Product Code KDI

K945596 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "ALTRES(R) 140 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on March 8, 1995. 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. Althin Medical AB an Affiliate of Baxter Intl has at least 10 other 510(k) clearances on record.