HyHub™ 及 HyHub™ Duo 藥劑針筒進入設備
K 號：K243404 · 2025-07-18
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決定日期2025-07-18
產品代碼LHI
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：LHI）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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