510(k) K143313

NxStage Therapeutic Plasma Exchange (TPE) Cartridge by Nxstage Medical, Inc. — Product Code KDI

K143313 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NxStage Therapeutic Plasma Exchange (TPE) Cartridge". The FDA issued a decision of Substantially Equivalent on March 20, 2015. 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. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.