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FDA 510(k)

CentroVena 中央靜脈針 (CVC) 配套使用 CentroVena 一體式植入系統

K 號：K242429 · 2025-04-09

申請人Becton Dickinson Inc. (Bd)
決定日期2025-04-09
產品代碼SEF
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

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Inc. (Bd). It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K242429. The device is classified under product code SEF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is a medical device that received FDA 510(k) clearance on 2025-04-09. The listed applicant is Becton Dickinson Inc. (Bd). The 510(k) number is K242429.

When did CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System receive FDA 510(k) clearance?

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System received FDA 510(k) clearance on 2025-04-09, under 510(k) number K242429.

Who is the listed applicant for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA 510(k) record lists Becton Dickinson Inc. (Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System?

The FDA product code for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is SEF.

相關臨床試驗

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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

官方來源

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