510(k) K182940

Surdial DX Hemodialysis System by Nipro Medical Corporation — Product Code KDI

K182940 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "Surdial DX Hemodialysis System". The FDA issued a decision of Substantially Equivalent on July 19, 2019. 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.