FDA 510(k)

驚波CS導管導引針

K 號：K243757 · 2025-05-02

決定日期2025-05-02

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Shockwave CS Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K243757. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Shockwave CS Guide Catheter?

Shockwave CS Guide Catheter is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K243757.

When did Shockwave CS Guide Catheter receive FDA 510(k) clearance?

Shockwave CS Guide Catheter received FDA 510(k) clearance on 2025-05-02, under 510(k) number K243757.

Who is the listed applicant for Shockwave CS Guide Catheter?

FDA 510(k) 記錄將 Shockwave Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Shockwave CS Guide Catheter?

The FDA product code for Shockwave CS Guide Catheter is DQY.

其他以 Shockwave Medical, Inc. 為申請人之記錄

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相關器械（代碼：DQY）

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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