510(k) K232467

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine by Baxter Healthcare Corporation — Product Code KDI

K232467 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "CleanCart A, CleanCart C, AK 98 Hemodialysis Machine". The FDA issued a decision of Substantially Equivalent on September 14, 2023. 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 Corporation has at least 10 other 510(k) clearances on record.