510(k) K122343

PUREFLUX-H HEMODIALYZER by Nipro Medical Corporation — Product Code KDI

K122343 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "PUREFLUX-H HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on May 7, 2013. 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. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.