510(k) K071518

DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS by B. Braun Medizintechnologie GmbH — Product Code KDI

K071518 is an FDA 510(k) premarket notification submitted by B. Braun Medizintechnologie GmbH for the device "DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on August 17, 2007. 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 Medizintechnologie GmbH has at least 2 other 510(k) clearances on record.