510(k) K903159

VALVE CONTROLLER FOR MICROMACRO COMPOUNDER by Baxa Corp., Sub. of Cook Group, Inc. — Product Code LHI

K903159 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "VALVE CONTROLLER FOR MICROMACRO COMPOUNDER". The FDA issued a decision of Substantially Equivalent on November 7, 1990. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.