FDA 510(k)

Sugita AVM Microclips

K号: K211183 · 2022-03-02

决定日期2022-03-02

产品代码HCH

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决定实质等同

器械摘要

Sugita AVM Microclips is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho America, Inc.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K211183. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sugita AVM Microclips?

Sugita AVM Microclips is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Mizuho America, Inc.. The 510(k) number is K211183.

When did Sugita AVM Microclips receive FDA 510(k) clearance?

Sugita AVM Microclips received FDA 510(k) clearance on 2022-03-02, under 510(k) number K211183.

Who is the listed applicant for Sugita AVM Microclips?

The FDA 510(k) record lists Mizuho America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sugita AVM Microclips?

The FDA product code for Sugita AVM Microclips is HCH.

列明Mizuho America, 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。

K221524Sugita AVM Microclip Applier

官方来源

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