510(k) K201809

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory by Baxter Healthcare Corportation — Product Code KDI

K201809 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corportation for the device "AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory". The FDA issued a decision of Substantially Equivalent on March 10, 2021. 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 Corportation has at least 2 other 510(k) clearances on record.