510(k) K954987

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM by Althin Medical AB an Affiliate of Baxter Intl — Product Code KDI

K954987 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 1996. 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.