510(k) K160444

FB-U Hemodialyzer by Nipro Medical Corporation — Product Code KDI

K160444 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "FB-U Hemodialyzer". The FDA issued a decision of Substantially Equivalent on February 8, 2017. 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.