FDA 510(k)

Nexiva™ 關閉式靜脈留置針系統搭配 NearPort™ 靜脈通路

K 號：K231239 · 2023-09-22

申請人Becton Dickinson Infusion Therapy Systems, Inc.

決定日期2023-09-22

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

Nexiva™ Closed IV Catheter System with NearPort™ IV Access 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 2023-09-22 under 510(k) number K231239. 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 Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

Nexiva™ Closed IV Catheter System with NearPort™ IV Access is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K231239.

When did Nexiva™ Closed IV Catheter System with NearPort™ IV Access receive FDA 510(k) clearance?

Nexiva™ Closed IV Catheter System with NearPort™ IV Access received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231239.

Who is the listed applicant for Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

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 Nexiva™ Closed IV Catheter System with NearPort™ IV Access?

The FDA product code for Nexiva™ Closed IV Catheter System with NearPort™ IV Access is FOZ.

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 K251654BD 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 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

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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 Vascular K261041ClearSafe 關閉系統MedSource Labs, LLC K260539MedSource QuickSafe™ 安全靜脈針管；MedSource PurSafe™ 安全靜脈針管MedSource Labs, LLC K253235Introcan 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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