510(k) K180615

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter by Fresenius Kabi USA,Llc — Product Code LKN

K180615 is an FDA 510(k) premarket notification submitted by Fresenius Kabi USA,Llc for the device "AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter". The FDA issued a decision of Substantially Equivalent on December 4, 2018. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fresenius Kabi USA,Llc has at least 1 other 510(k) clearance on record.