FDA 510(k)

BD SmartSite™ 非針刺接頭

K 號：K223088 · 2023-04-07

決定日期2023-04-07

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

BD SmartSite™ Needle-Free Connector is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223088. 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 BD SmartSite™ Needle-Free Connector?

BD SmartSite™ Needle-Free Connector is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Care Fusion. The 510(k) number is K223088.

When did BD SmartSite™ Needle-Free Connector receive FDA 510(k) clearance?

BD SmartSite™ Needle-Free Connector received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223088.

Who is the listed applicant for BD SmartSite™ Needle-Free Connector?

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™ Needle-Free Connector?

The FDA product code for BD SmartSite™ Needle-Free Connector is FPA.

其他以 Care Fusion 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。

K233021BD SmartSite™ 13mm 瓶蓋接入設備；BD SmartSite™ 20mm 瓶蓋接入設備 K231888BD Texium™ 非針筒注射器 K221319BD Alaris™ 泵硬脊膜外輸液套組 K221327BD Alaris™ 泵輸液套組 K223101BD 二次輸液設備 K223076BD Texium™ 關閉男性 Luer

查看所有 14 項裝置 →

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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