FDA 510(k)

Vented Vial Adapter Transfer Device - 13mm

Номер K: K160503 · 2016-05-04

Дата решения2016-05-04

Код продуктаLHI

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Vented Vial Adapter Transfer Device - 13mm is the device name listed in this FDA 510(k) record. The listed applicant is Medimop Medical Projects, Ltd.. It received FDA 510(k) clearance on 2016-05-04 under 510(k) number K160503. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vented Vial Adapter Transfer Device - 13mm?

Vented Vial Adapter Transfer Device - 13mm is a medical device that received FDA 510(k) clearance on 2016-05-04. The listed applicant is Medimop Medical Projects, Ltd.. The 510(k) number is K160503.

When did Vented Vial Adapter Transfer Device - 13mm receive FDA 510(k) clearance?

Vented Vial Adapter Transfer Device - 13mm received FDA 510(k) clearance on 2016-05-04, under 510(k) number K160503.

Who is the listed applicant for Vented Vial Adapter Transfer Device - 13mm?

The FDA 510(k) record lists Medimop Medical Projects, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vented Vial Adapter Transfer Device - 13mm?

The FDA product code for Vented Vial Adapter Transfer Device - 13mm is LHI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LHI)

K252987ADRx® Приготовительное устройствоEpic 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

Официальный источник

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