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FDA 510(k)

Vial2Bag Advanced 20mm Admixture Device

N.º K: K201415 · 2020-10-21

SolicitanteWest Pharmaceutical Services Az, Inc.
Fecha de decisión2020-10-21
Código de productoLHI
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vial2Bag Advanced 20mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharmaceutical Services Az, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K201415. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vial2Bag Advanced 20mm Admixture Device?

Vial2Bag Advanced 20mm Admixture Device is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is West Pharmaceutical Services Az, Inc.. The 510(k) number is K201415.

When did Vial2Bag Advanced 20mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced 20mm Admixture Device received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201415.

Who is the listed applicant for Vial2Bag Advanced 20mm Admixture Device?

The FDA 510(k) record lists West Pharmaceutical Services Az, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial2Bag Advanced 20mm Admixture Device?

The FDA product code for Vial2Bag Advanced 20mm Admixture Device is LHI.

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Dispositivos relacionados (Código: LHI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252987ADRx® Dispositivo de MezclaEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline 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, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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