FDA 510(k)

AneuGuide

K号: K213838 · 2022-06-01

决定日期2022-06-01

产品代码PZO

咨询委员会RA

决定实质等同

器械摘要

AneuGuide is the device name listed in this FDA 510(k) record. The listed applicant is ArteryFlow Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K213838. The device is classified under product code PZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AneuGuide?

AneuGuide is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is ArteryFlow Technology Co., Ltd.. The 510(k) number is K213838.

When did AneuGuide receive FDA 510(k) clearance?

AneuGuide received FDA 510(k) clearance on 2022-06-01, under 510(k) number K213838.

Who is the listed applicant for AneuGuide?

The FDA 510(k) record lists ArteryFlow Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AneuGuide?

The FDA product code for AneuGuide is PZO.

列明ArteryFlow Technology Co., Ltd.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。

K231353AccuCTP Pro K230303AccuFFRangio Plus K221711AccuICAS K220663AccuCTP K210093AccuFFRangio

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