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FDA 510(k)

BD SmartSite™ Needle-Free Connector

K-Number: K223088 · 2023-04-07

ApplicantCare Fusion
Decision Date2023-04-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD SmartSite™ Needle-Free Connector is a medical device manufactured by Care Fusion. It received FDA 510(k) clearance on 2023-04-07 under approval number K223088. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD SmartSite™ Needle-Free Connector?

BD SmartSite™ Needle-Free Connector is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Care Fusion. The 510(k) number is K223088.

When was BD SmartSite™ Needle-Free Connector approved by the FDA?

BD SmartSite™ Needle-Free Connector received FDA 510(k) clearance on 2023-04-07, under approval number K223088.

What company makes BD SmartSite™ Needle-Free Connector?

BD SmartSite™ Needle-Free Connector is manufactured by Care Fusion.

What is the FDA product code for BD SmartSite™ Needle-Free Connector?

The FDA product code for BD SmartSite™ Needle-Free Connector is FPA.

Related Clinical Trials

NCT07519304 Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial NOT_YET_RECRUITING

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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.

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