FDA 510(k)

Introcan Safety® 深部接入 XL 静脉留置针

K号: K253235 · 2026-05-15

决定日期2026-05-15

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

Introcan Safety® Deep Access XL IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K253235. 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 Introcan Safety® Deep Access XL IV Catheter?

Introcan Safety® Deep Access XL IV Catheter is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K253235.

When did Introcan Safety® Deep Access XL IV Catheter receive FDA 510(k) clearance?

Introcan Safety® Deep Access XL IV Catheter received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253235.

Who is the listed applicant for Introcan Safety® Deep Access XL IV Catheter?

FDA 510(k)记录中列出了B.Braun Medical, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Introcan Safety® Deep Access XL IV Catheter?

The FDA product code for Introcan Safety® Deep Access XL IV Catheter is FOZ.

列明B.Braun Medical, 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。

K254111灌洗/泌尿科套装 K243392Infusomat® Space 体积输液泵给药套装 K240578VenaTech® LP 腔静脉滤器系统和 VenaTech® 可转换腔静脉滤器系统 K241845Introcan Safety® 2 静脉留置针 K241385Omnifix 注射器 NRFit K231242Perifix FX 球囊导管；Contiplex FX 球囊导管

查看所有 35 个设备 →

相关器械（代码：FOZ）

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。

K260432Ruby 介入导管Venocare, Inc.K260165未浸渍中心静脉导管Spectrum Vascular K261041ClearSafe封闭系统MedSource Labs, LLC K260539MedSource QuickSafe™ 安全静脉留置针；MedSource PurSafe™ 安全静脉留置针MedSource Labs, LLC K252137BD Insyte™ IV 管套Becton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety（14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm；20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm，26G x 14mm）；Polywin Safety Adva（20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm；14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm，26G x 14mm）Poly Medicure Limited

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。