FDA 510(k)

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

Número K: K233021 · 2024-03-06

Data da decisão2024-03-06

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Care Fusion. The 510(k) number is K233021.

When did BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device receive FDA 510(k) clearance?

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

Who is the listed applicant for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

The FDA 510(k) record lists Care Fusion as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Care Fusion como candidato(a)

K231888BD Texium™ Needle-Free Syringe K221327BD Alaris™ Pump Infusion Sets K221319BD Alaris™ Pump Epidural Infusion Set K223101BD Secondary Infusion Set K223088BD SmartSite™ Needle-Free Connector K223076BD Texium™ Closed Male Luer

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Dispositivos Relacionados (Código: LHI)

K252987ADRx® Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LP K251715FlowArt® Vial Access Device VentedAsset Medikal K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLC K243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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