510(k) K090917

SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM by Baxa Corp. — Product Code LHI

K090917 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 19, 2010. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxa Corp. has at least 7 other 510(k) clearances on record.