510(k) K232803

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) by Nxstage Medical, Inc. — Product Code KDI

K232803 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)". The FDA issued a decision of Substantially Equivalent on March 14, 2024. 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.