510(k) K052790

SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD by Cardinal Health, Alaris Products — Product Code LHI

K052790 is an FDA 510(k) premarket notification submitted by Cardinal Health, Alaris Products for the device "SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD". The FDA issued a decision of Substantially Equivalent on December 23, 2005. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Cardinal Health, Alaris Products has at least 8 other 510(k) clearances on record.