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FDA 510(k)

ClearPath 一次性導入器

K 號:K210251 · 2021-04-02

決定日期2021-04-02
產品代碼GWG
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

ClearPath Disposable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K210251. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ClearPath Disposable Introducer?

ClearPath Disposable Introducer is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Clearmind Biomedical. The 510(k) number is K210251.

When did ClearPath Disposable Introducer receive FDA 510(k) clearance?

ClearPath Disposable Introducer received FDA 510(k) clearance on 2021-04-02, under 510(k) number K210251.

Who is the listed applicant for ClearPath Disposable Introducer?

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

What is the FDA product code for ClearPath Disposable Introducer?

The FDA product code for ClearPath Disposable Introducer is GWG.

相關臨床試驗

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其他以 Clearmind Biomedical 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。

相關器械(代碼:GWG)

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。

官方來源

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