FDA 510(k)

內血管延伸套件及附件

K 號：K242339 · 2025-02-28

決定日期2025-02-28

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

Intravascular Extension Sets and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K242339. 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 Intravascular Extension Sets and Accessories?

Intravascular Extension Sets and Accessories is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K242339.

When did Intravascular Extension Sets and Accessories receive FDA 510(k) clearance?

Intravascular Extension Sets and Accessories received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242339.

Who is the listed applicant for Intravascular Extension Sets and Accessories?

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

What is the FDA product code for Intravascular Extension Sets and Accessories?

The FDA product code for Intravascular Extension Sets and Accessories is FPA.

其他以 Baxter Healthcare Corporation 為申請人之記錄

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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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, LLC K261530iiSure 靜脈輸注套件Deka Research and Development K252543AMSafe 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 Medical K250325BD Alaris 泵輸注套件Carefusion (Bd)

官方來源

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