FDA 510(k)

BD Texium™ Needle-Free Syringe

Número K: K231888 · 2023-09-25

Data da decisão2023-09-25

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Texium™ Needle-Free Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231888. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Texium™ Needle-Free Syringe?

BD Texium™ Needle-Free Syringe is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Care Fusion. The 510(k) number is K231888.

When did BD Texium™ Needle-Free Syringe receive FDA 510(k) clearance?

BD Texium™ Needle-Free Syringe received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231888.

Who is the listed applicant for BD Texium™ Needle-Free Syringe?

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 Texium™ Needle-Free Syringe?

The FDA product code for BD Texium™ Needle-Free Syringe is FMF.

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Outros registros que listam Care Fusion como candidato(a)

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device 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: FMF)

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Fonte oficial

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