FDA 510(k)

HyHub™ and HyHub™ Duo Vial Access Devices

Número K: K243404 · 2025-07-18

Data da decisão2025-07-18

Código do produtoLHI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HyHub™ and HyHub™ Duo Vial Access Devices is the device name listed in this FDA 510(k) record. The listed applicant is Takeda Pharmaceuticals. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K243404. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HyHub™ and HyHub™ Duo Vial Access Devices?

HyHub™ and HyHub™ Duo Vial Access Devices is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Takeda Pharmaceuticals. The 510(k) number is K243404.

When did HyHub™ and HyHub™ Duo Vial Access Devices receive FDA 510(k) clearance?

HyHub™ and HyHub™ Duo Vial Access Devices received FDA 510(k) clearance on 2025-07-18, under 510(k) number K243404.

Who is the listed applicant for HyHub™ and HyHub™ Duo Vial Access Devices?

The FDA 510(k) record lists Takeda Pharmaceuticals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyHub™ and HyHub™ Duo Vial Access Devices?

The FDA product code for HyHub™ and HyHub™ Duo Vial Access Devices is LHI.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LHI)

K252987ADRx® Admixture DeviceEpic 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 K240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.