510(k) K233021

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device by Care Fusion — Product Code LHI

K233021 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device". The FDA issued a decision of Substantially Equivalent on March 6, 2024. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Care Fusion has at least 10 other 510(k) clearances on record.