510(k) K251715

FlowArt® Vial Access Device Vented by Asset Medikal — Product Code LHI

K251715 is an FDA 510(k) premarket notification submitted by Asset Medikal for the device "FlowArt® Vial Access Device Vented". The FDA issued a decision of Substantially Equivalent on October 14, 2025. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440.