510(k) K002892

FRSENIUS PD IQCARD CYCLER by Fresenius Medical Care North America — Product Code FKX

K002892 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRSENIUS PD IQCARD CYCLER". The FDA issued a decision of Substantially Equivalent on April 5, 2001. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.