510(k) K212216

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set by Baxter Healthcare Corporation — Product Code KDI

K212216 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set". The FDA issued a decision of Substantially Equivalent on April 1, 2022. 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.