FDA 510(k)

Lunderquist 頗硬導絲指引

K 號：K251596 · 2025-11-09

決定日期2025-11-09

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Lunderquist Extra Stiff Wire Guide is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2025-11-09 under 510(k) number K251596. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lunderquist Extra Stiff Wire Guide?

Lunderquist Extra Stiff Wire Guide is a medical device that received FDA 510(k) clearance on 2025-11-09. The listed applicant is William Cook Europe Aps. The 510(k) number is K251596.

When did Lunderquist Extra Stiff Wire Guide receive FDA 510(k) clearance?

Lunderquist Extra Stiff Wire Guide received FDA 510(k) clearance on 2025-11-09, under 510(k) number K251596.

Who is the listed applicant for Lunderquist Extra Stiff Wire Guide?

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

What is the FDA product code for Lunderquist Extra Stiff Wire Guide?

The FDA product code for Lunderquist Extra Stiff Wire Guide is DQX.

其他以 William Cook Europe Aps 為申請人之記錄

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相關器械（代碼：DQX）

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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