FDA 510(k)

Thrombuster II 吸引針管

K 號：K213166 · 2021-10-26

決定日期2021-10-26

產品代碼QEZ

諮詢委員會履歷

決定相當於

器材摘要

Thrombuster II Aspiration Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K213166. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Thrombuster II Aspiration Catheter?

Thrombuster II Aspiration Catheter is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is Kaneka Medical America, LLC. The 510(k) number is K213166.

When did Thrombuster II Aspiration Catheter receive FDA 510(k) clearance?

Thrombuster II Aspiration Catheter received FDA 510(k) clearance on 2021-10-26, under 510(k) number K213166.

Who is the listed applicant for Thrombuster II Aspiration Catheter?

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

What is the FDA product code for Thrombuster II Aspiration Catheter?

The FDA product code for Thrombuster II Aspiration Catheter is QEZ.

其他以 Kaneka Medical America, LLC 為申請人之記錄

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相關器械（代碼：QEZ）

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。

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官方來源

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