510(k) K111702

AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE by Fenwal, Inc. — Product Code LKN

K111702 is an FDA 510(k) premarket notification submitted by Fenwal, Inc. for the device "AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE". The FDA issued a decision of Substantially Equivalent on March 22, 2012. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fenwal, Inc. has at least 2 other 510(k) clearances on record.