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FDA 510(k)

Equashield Closed System drug Transfer Device (CSTD)

N.º K: K170706 · 2017-07-03

SolicitanteEquashield Medical , Ltd.
Fecha de decisión2017-07-03
Código de productoONB
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Equashield Closed System drug Transfer Device (CSTD) is the device name listed in this FDA 510(k) record. The listed applicant is Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170706. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Equashield Closed System drug Transfer Device (CSTD)?

Equashield Closed System drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Equashield Medical , Ltd.. The 510(k) number is K170706.

When did Equashield Closed System drug Transfer Device (CSTD) receive FDA 510(k) clearance?

Equashield Closed System drug Transfer Device (CSTD) received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170706.

Who is the listed applicant for Equashield Closed System drug Transfer Device (CSTD)?

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

What is the FDA product code for Equashield Closed System drug Transfer Device (CSTD)?

The FDA product code for Equashield Closed System drug Transfer Device (CSTD) is ONB.

Ensayos clínicos relacionados

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Otros registros que enlistan a Equashield Medical , Ltd. como solicitante

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.

K221513Equashield Closed System Transfer Device

Dispositivos relacionados (Código: ONB)

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.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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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