510(k) K100334

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 by B. Braun Avitum AG — Product Code KDI

K100334 is an FDA 510(k) premarket notification submitted by B. Braun Avitum AG for the device "DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811". The FDA issued a decision of Substantially Equivalent on Apr 22, 2010. 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. B. Braun Avitum AG has 4 other 510(k) clearances on record.