HyHub™ 和 HyHub™ Duo 瓶盖访问设备
K号: K243404 · 2025-07-18
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决定日期2025-07-18
产品代码LHI
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：LHI）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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