510(k) K172631

Arisure Dry Spike by Yukon Medical — Product Code LHI

K172631 is an FDA 510(k) premarket notification submitted by Yukon Medical for the device "Arisure Dry Spike". The FDA issued a decision of Substantially Equivalent on September 29, 2017. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Yukon Medical has at least 10 other 510(k) clearances on record.