FDA 510(k)

超大檢查通導管

K 號：K203670 · 2021-02-16

決定日期2021-02-16

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Extra Large Check-Flo Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K203670. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Extra Large Check-Flo Introducer?

Extra Large Check-Flo Introducer is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Cook Incorporated. The 510(k) number is K203670.

When did Extra Large Check-Flo Introducer receive FDA 510(k) clearance?

Extra Large Check-Flo Introducer received FDA 510(k) clearance on 2021-02-16, under 510(k) number K203670.

Who is the listed applicant for Extra Large Check-Flo Introducer?

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 Extra Large Check-Flo Introducer?

The FDA product code for Extra Large Check-Flo Introducer is DYB.

其他以 Cook Incorporated 為申請人之記錄

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相關器械（代碼：DYB）

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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