FDA 510(k)

OnGuard2 Chemfort Closed Administration (CADM)

N.º K: K210707 · 2021-09-23

Fecha de decisión2021-09-23

Código de productoONB

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

OnGuard2 Chemfort Closed Administration (CADM) is the device name listed in this FDA 510(k) record. The listed applicant is Simplivia Healthcare , Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K210707. 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 OnGuard2 Chemfort Closed Administration (CADM)?

OnGuard2 Chemfort Closed Administration (CADM) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K210707.

When did OnGuard2 Chemfort Closed Administration (CADM) receive FDA 510(k) clearance?

OnGuard2 Chemfort Closed Administration (CADM) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K210707.

Who is the listed applicant for OnGuard2 Chemfort Closed Administration (CADM)?

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

What is the FDA product code for OnGuard2 Chemfort Closed Administration (CADM)?

The FDA product code for OnGuard2 Chemfort Closed Administration (CADM) is ONB.

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Otros registros que enlistan a Simplivia Healthcare , Ltd. como solicitante

K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor K251411Chemfort Female Luer Lock Adaptor K231286Chemfort® Catheter Adaptor K201142TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set K192866Chemfort CSTD

Dispositivos relacionados (Código: ONB)

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 Company K251411Chemfort 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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