FDA 510(k)

鈴木AVM微釘

K 號：K211183 · 2022-03-02

決定日期2022-03-02

產品代碼HCH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Mizuho America, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221524鈴木AVM微釘應用器

相關器械（代碼：HCH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K180757D-Clip；D-Clip 應用器Peter Lazic GmbH

官方來源

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