Leaderflex Mini 和 Leaderflex Nano
K号: K212370 · 2022-08-29
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申请人Vygon USA
决定日期2022-08-29
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
Leaderflex Mini and Leaderflex Nano is the device name listed in this FDA 510(k) record. The listed applicant is Vygon USA. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K212370. 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 Leaderflex Mini and Leaderflex Nano?
Leaderflex Mini and Leaderflex Nano is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Vygon USA. The 510(k) number is K212370.
When did Leaderflex Mini and Leaderflex Nano receive FDA 510(k) clearance?
Leaderflex Mini and Leaderflex Nano received FDA 510(k) clearance on 2022-08-29, under 510(k) number K212370.
Who is the listed applicant for Leaderflex Mini and Leaderflex Nano?
The FDA 510(k) record lists Vygon USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Leaderflex Mini and Leaderflex Nano?
The FDA product code for Leaderflex Mini and Leaderflex Nano 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Vygon USA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。
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.K252137BD Insyte™ IV 管套Becton Dickinson Infusion Therapy Systems, Inc.
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。
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