510(k) K122265

VIALOK SINGLE VIAL ACCESS DEVICE VENTED by Yukon Medical, LLC — Product Code LHI

K122265 is an FDA 510(k) premarket notification submitted by Yukon Medical, LLC for the device "VIALOK SINGLE VIAL ACCESS DEVICE VENTED". The FDA issued a decision of Substantially Equivalent on August 14, 2012. 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.