510(k) K050273

FRESENIUS ART HEMOADSORPTION SYSTEM by Fresenius Medical Care North America — Product Code LKN

K050273 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS ART HEMOADSORPTION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 2005. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.