510(k) K232987

FlowArt Valve for Vial Access by Asset Medikal Tasarim Sanayi VE Ticaret A.S. — Product Code LHI

K232987 is an FDA 510(k) premarket notification submitted by Asset Medikal Tasarim Sanayi VE Ticaret A.S. for the device "FlowArt Valve for Vial Access". The FDA issued a decision of Substantially Equivalent on June 26, 2024. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440.