FDA 510(k)

BD SmartSite™ 13mm 瓶蓋接入設備；BD SmartSite™ 20mm 瓶蓋接入設備

K 號：K233021 · 2024-03-06

決定日期2024-03-06

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

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K233021. 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 BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Care Fusion. The 510(k) number is K233021.

When did BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device receive FDA 510(k) clearance?

BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device received FDA 510(k) clearance on 2024-03-06, under 510(k) number K233021.

Who is the listed applicant for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

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

What is the FDA product code for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device?

The FDA product code for BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device is LHI.

其他以 Care Fusion 為申請人之記錄

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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。

K252987ADRx® 混合設備Epic Medical Pte. , Ltd.K260301藥劑適配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345美林袋式分酒器Medline Industries, LP K251715FlowArt® 輸液針筒進入設備通氣Asset Medikal K251676Medline Microtek C-Flo Bag Decanter, 適用於無菌 (2000S)；Medline Microtek Bag Decanter II，適用於無菌 (2002S)；Medline Microtek Vial Decanter，適用於無菌 (2006S)；Medline Microtek Transfer Device，適用於無菌 (2008S)Microtek Medical, LLC K243404HyHub™ 及 HyHub™ Duo 藥劑針筒進入設備Takeda Pharmaceuticals

官方來源

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