510(k) K132863

SMARTSITE VIALSHIELD by Yukon Medical, LLC — Product Code LHI

K132863 is an FDA 510(k) premarket notification submitted by Yukon Medical, LLC for the device "SMARTSITE VIALSHIELD". The FDA issued a decision of Substantially Equivalent on October 4, 2013. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Yukon Medical, LLC has at least 10 other 510(k) clearances on record.