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FDA 510(k)

TEVADAPTOR Closed Drug Reconstitution and Transfer System

N.º K: K180489 · 2018-09-21

SolicitanteTeva Medical Ltd., Migada Plant
Fecha de decisión2018-09-21
Código de productoONB
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

TEVADAPTOR Closed Drug Reconstitution and Transfer System is the device name listed in this FDA 510(k) record. The listed applicant is Teva Medical Ltd., Migada Plant. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K180489. 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 TEVADAPTOR Closed Drug Reconstitution and Transfer System?

TEVADAPTOR Closed Drug Reconstitution and Transfer System is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Teva Medical Ltd., Migada Plant. The 510(k) number is K180489.

When did TEVADAPTOR Closed Drug Reconstitution and Transfer System receive FDA 510(k) clearance?

TEVADAPTOR Closed Drug Reconstitution and Transfer System received FDA 510(k) clearance on 2018-09-21, under 510(k) number K180489.

Who is the listed applicant for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

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

What is the FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System?

The FDA product code for TEVADAPTOR Closed Drug Reconstitution and Transfer System is ONB.

Ensayos clínicos relacionados

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Otros registros que enlistan a Teva Medical Ltd., Migada Plant 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.

K170680TEVADAPTOR Closed Drug Reconstitution and Transfer System

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

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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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