510(k) K122051

NXSTAGE SYSTEM ONE by Nxstage Medical, Inc. — Product Code KDI

K122051 is an FDA 510(k) premarket notification submitted by Nxstage Medical, Inc. for the device "NXSTAGE SYSTEM ONE". The FDA issued a decision of Substantially Equivalent on April 23, 2013. 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.