510(k) K013562

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE by Baxter Healthcare Corp — Product Code KDI

K013562 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE". The FDA issued a decision of Substantially Equivalent on Dec 12, 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.