FlowArt 靈媒閥門用於安瓿瓶接取
K 號：K232987 · 2024-06-26
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決定日期2024-06-26
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
FlowArt Valve for Vial Access is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal Tasarim Sanayi VE Ticaret A.S.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K232987. 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 FlowArt Valve for Vial Access?
FlowArt Valve for Vial Access is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Asset Medikal Tasarim Sanayi VE Ticaret A.S.. The 510(k) number is K232987.
When did FlowArt Valve for Vial Access receive FDA 510(k) clearance?
FlowArt Valve for Vial Access received FDA 510(k) clearance on 2024-06-26, under 510(k) number K232987.
Who is the listed applicant for FlowArt Valve for Vial Access?
The FDA 510(k) record lists Asset Medikal Tasarim Sanayi VE Ticaret A.S. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FlowArt Valve for Vial Access?
The FDA product code for FlowArt Valve for Vial Access 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。
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, LPK251715FlowArt® 輸液針筒進入設備 通氣Asset MedikalK251676Medline 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, LLCK243404HyHub™ 及 HyHub™ Duo 藥劑針筒進入設備Takeda Pharmaceuticals
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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