FDA 510(k)

科西恩-10TM 診斷導管

K 號：K233397 · 2023-12-02

決定日期2023-12-02

產品代碼DRF

諮詢委員會履歷

決定相當於

器材摘要

Cosine-10TM Diagnostic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-12-02 under 510(k) number K233397. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cosine-10TM Diagnostic Catheter?

Cosine-10TM Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2023-12-02. The listed applicant is Medtronic, Inc.. The 510(k) number is K233397.

When did Cosine-10TM Diagnostic Catheter receive FDA 510(k) clearance?

Cosine-10TM Diagnostic Catheter received FDA 510(k) clearance on 2023-12-02, under 510(k) number K233397.

Who is the listed applicant for Cosine-10TM Diagnostic Catheter?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Cosine-10TM Diagnostic Catheter?

The FDA product code for Cosine-10TM Diagnostic Catheter is DRF.

其他以 Medtronic, Inc. 為申請人之記錄

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相關器械（代碼：DRF）

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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