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FDA 510(k)

BD Insyte® Autoguard® 遮蔽 I.V. 穿刺針，BD Insyte® Autoguard® BC 遮蔽 I.V. 穿刺針和 BD Insyte® Autoguard® BC Pro 遮蔽 I.V. 穿刺針

K 號：K251654 · 2025-06-27

申請人Becton Dickinson Infusion Therapy Systems, Inc.
決定日期2025-06-27
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

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251654. 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 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K251654.

When did BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter receive FDA 510(k) clearance?

BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251654.

Who is the listed applicant for BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

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

What is the FDA product code for BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter?

The FDA product code for BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV 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 Becton Dickinson Infusion Therapy Systems, Inc. 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。

K252137BD Insyte® I.V. 穿刺針K251422BD Saf-T-Intima™ 皮下单腔導管系統K243403BD Nexiva™ 關閉式靜脈留置針系統K251155BD Cathena™ 安全 I.V. 静脈針K250682BD Nexiva™ Diffusics™ 關閉式靜脈留置針系統及BD Nexiva™ Diffusics™ 關閉式靜脈留置針系統配BD MaxZero™ 非針接頭K241586PIVO™ Pro 非針式血液採集設備

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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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