510(k) K083778

XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 by Baxter Healthcare Corporation — Product Code KDI

K083778 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210". The FDA issued a decision of Substantially Equivalent on Feb 20, 2009. 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.