FDA 510(k)

Velano ExT 扩展套件

K号: K200439 · 2021-02-23

决定日期2021-02-23

产品代码FPA

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

Velano ExT Extension Set is the device name listed in this FDA 510(k) record. The listed applicant is Velano Vascular. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K200439. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Velano ExT Extension Set?

Velano ExT Extension Set is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Velano Vascular. The 510(k) number is K200439.

When did Velano ExT Extension Set receive FDA 510(k) clearance?

Velano ExT Extension Set received FDA 510(k) clearance on 2021-02-23, under 510(k) number K200439.

Who is the listed applicant for Velano ExT Extension Set?

The FDA 510(k) record lists Velano Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velano ExT Extension Set?

The FDA product code for Velano ExT Extension Set is FPA.

列明Velano Vascular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。

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相关器械（代码：FPA）

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。

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官方来源

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