FDA 510(k)

Vial2Bag Advanced® 13mm Admixture Device

Número K: K230988 · 2023-12-01

RequerenteWest Pharma. Services IL, Ltd.

Data da decisão2023-12-01

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vial2Bag Advanced® 13mm Admixture Device is the device name listed in this FDA 510(k) record. The listed applicant is West Pharma. Services IL, Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230988. 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 Vial2Bag Advanced® 13mm Admixture Device?

Vial2Bag Advanced® 13mm Admixture Device is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is West Pharma. Services IL, Ltd.. The 510(k) number is K230988.

When did Vial2Bag Advanced® 13mm Admixture Device receive FDA 510(k) clearance?

Vial2Bag Advanced® 13mm Admixture Device received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230988.

Who is the listed applicant for Vial2Bag Advanced® 13mm Admixture Device?

The FDA 510(k) record lists West Pharma. Services IL, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vial2Bag Advanced® 13mm Admixture Device?

The FDA product code for Vial2Bag Advanced® 13mm Admixture Device is LHI.

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Fonte oficial

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