FDA 510(k)

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

N.º K: K253033 · 2025-10-21

Fecha de decisión2025-10-21

Código de productoONB

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor 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 2025-10-21 under 510(k) number K253033. 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 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Simplivia Healthcare , Ltd.. The 510(k) number is K253033.

When did Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor receive FDA 510(k) clearance?

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor received FDA 510(k) clearance on 2025-10-21, under 510(k) number K253033.

Who is the listed applicant for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

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 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

The FDA product code for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor is ONB.

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

K251411Chemfort Female Luer Lock Adaptor K231286Chemfort® Catheter Adaptor K210707OnGuard2 Chemfort Closed Administration (CADM)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.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.K240517ProSeal™ Vented Universal Vial AdaptorEpic Medical Pte. , Ltd.

Fuente oficial

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