穩定設置輸液器
K 號：K251854 · 2025-08-06
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決定日期2025-08-06
產品代碼FPA
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
SteadiSet infusion set is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K251854. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SteadiSet infusion set?
SteadiSet infusion set is a medical device that received FDA 510(k) clearance on 2025-08-06. The listed applicant is Tandem Diabetes Care. The 510(k) number is K251854.
When did SteadiSet infusion set receive FDA 510(k) clearance?
SteadiSet infusion set received FDA 510(k) clearance on 2025-08-06, under 510(k) number K251854.
Who is the listed applicant for SteadiSet infusion set?
The FDA 510(k) record lists Tandem Diabetes Care as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SteadiSet infusion set?
The FDA product code for SteadiSet infusion set is FPA.
相關臨床試驗
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。
相關器械（代碼：FPA）
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。
K254123Ecomed 一次性注射用藥物輸注套件Ecomed Solutions, LLCK261530iiSure 靜脈輸注套件Deka Research and DevelopmentK252543AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath 火飛無針連接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵輸注套件Carefusion (Bd)
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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