510(k) K213639

Revaclear 500, Revaclear 400, Revaclear 300 by Baxter Healthcare Corporation — Product Code KDI

K213639 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Revaclear 500, Revaclear 400, Revaclear 300". The FDA issued a decision of Substantially Equivalent on Jan 24, 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 60 other 510(k) clearances on record.