FDA 510(k)

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device

K-Number: K233021 · 2024-03-06

Decision Date2024-03-06

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device is a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2024-03-06 under approval number K233021. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device?

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device is a medical device that received FDA 510(k) clearance on 2024-03-06. It is manufactured by Care Fusion. The 510(k) number is K233021.

When was BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device approved by the FDA?

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device received FDA 510(k) clearance on 2024-03-06, under approval number K233021.

What company makes BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device?

BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device is manufactured by Care Fusion.

What is the FDA product code for BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device?

The FDA product code for BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device is LHI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.