510(k) K914363

PERITONEAL DIALYSIS CYCLER SET by National Medical Care, Medical Products Div., Inc. — Product Code KDI

K914363 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "PERITONEAL DIALYSIS CYCLER SET". The FDA issued a decision of Substantially Equivalent on March 16, 1992. 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. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.