BD Insyte™ IV 管套
K号: K252137 · 2026-04-02
广告
决定日期2026-04-02
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
BD Insyte™ 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 2026-04-02 under 510(k) number K252137. 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 BD Insyte™ IV Catheter?
BD Insyte™ IV Catheter is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K252137.
When did BD Insyte™ IV Catheter receive FDA 510(k) clearance?
BD Insyte™ IV Catheter received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252137.
Who is the listed applicant for BD Insyte™ 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™ IV Catheter?
The FDA product code for BD Insyte™ IV Catheter is FOZ.
相关临床试验
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。
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。
K251422BD Saf-T-Intima™ 皮下导管系统K243403BD Nexiva™ Closed IV Catheter SystemK251155BD 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K241586PIVO® Pro 无针血液采集装置
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 VascularK261041ClearSafe封闭系统MedSource Labs, LLCK260539MedSource QuickSafe™ 安全静脉留置针；MedSource PurSafe™ 安全静脉留置针MedSource Labs, LLCK253235Introcan Safety® 深部接入 XL 静脉留置针B.Braun Medical, 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。
广告