FDA 510(k)

Nexiva® 近端Port® 静脉导管系统

K号: K231239 · 2023-09-22

申请人Becton Dickinson Infusion Therapy Systems, Inc.

决定日期2023-09-22

产品代码FOZ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Becton Dickinson Infusion Therapy Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252137BD Insyte™ IV 管套 K251422BD Saf-T-Intima™ 皮下导管系统 K243403BD Nexiva™ Closed IV Catheter System K251155BD Cathena™ 安全静脉留置针 K251654BD Insyte™ Autoguard™ 隔离 IV 管套, BD Insyte™ Autoguard™ BC 隔离 IV 管套和 BD Insyte™ Autoguard™ BC Pro 隔离 IV 管套 K250682BD Nexiva® Diffusics® 闭式静脉导管系统及BD Nexiva® Diffusics® 闭式静脉导管系统与BD MaxZero® 无针连接器

查看所有 16 个设备 →

官方来源

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