FDA 510(k)

內血管擴張器及套件

K 號：K210734 · 2021-04-06

決定日期2021-04-06

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

Endovascular Dilator and Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K210734. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endovascular Dilator and Sets?

Endovascular Dilator and Sets is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Cook Incorporated. The 510(k) number is K210734.

When did Endovascular Dilator and Sets receive FDA 510(k) clearance?

Endovascular Dilator and Sets received FDA 510(k) clearance on 2021-04-06, under 510(k) number K210734.

Who is the listed applicant for Endovascular Dilator and Sets?

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

What is the FDA product code for Endovascular Dilator and Sets?

The FDA product code for Endovascular Dilator and Sets is DRE.

其他以 Cook Incorporated 為申請人之記錄

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相關器械（代碼：DRE）

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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