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FDA 510(k)

MedSource TrueSafe 血壓控制 I.V. 安全針頭，以及 MedSource ClearSafe 血壓控制 I.V. 安全針頭

K 號：K223788 · 2023-09-15

申請人Medsource International, LLC
決定日期2023-09-15
產品代碼FOZ
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

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medsource International, LLC. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K223788. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Medsource International, LLC. The 510(k) number is K223788.

When did The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter receive FDA 510(k) clearance?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter received FDA 510(k) clearance on 2023-09-15, under 510(k) number K223788.

Who is the listed applicant for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The FDA 510(k) record lists Medsource International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is FOZ.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Medsource International, LLC 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。

K161779MedSource 真安全安全靜脈針管，MedSource 真安全舒適安全靜脈針管

相關器械（代碼：FOZ）

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。

K260432Ruby 靜脈內導管Venocare, Inc.K260165未浸潤中心靜脈針管Spectrum VascularK261041ClearSafe 關閉系統MedSource Labs, LLCK260539MedSource QuickSafe™ 安全靜脈針管；MedSource PurSafe™ 安全靜脈針管MedSource Labs, LLCK253235Introcan Safety® 深層進入XL IV 腔管B.Braun Medical, Inc.K252137BD Insyte® I.V. 穿刺針Becton Dickinson Infusion Therapy Systems, Inc.

官方來源

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