510(k) K183158

NxStage Cartridge Express with Speedswap by Nxstage Medical, Inc. — Product Code KDI

K183158 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NxStage Cartridge Express with Speedswap". The FDA issued a decision of Substantially Equivalent on August 9, 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. Nxstage Medical, Inc. has at least 10 other 510(k) clearances on record.