FDA 510(k)

望遠鏡導管延伸針管

K 號：K252390 · 2025-10-29

決定日期2025-10-29

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

Telescope Guide Extension Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Ireland. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K252390. 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 Telescope Guide Extension Catheter?

Telescope Guide Extension Catheter is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Medtronic, Ireland. The 510(k) number is K252390.

When did Telescope Guide Extension Catheter receive FDA 510(k) clearance?

Telescope Guide Extension Catheter received FDA 510(k) clearance on 2025-10-29, under 510(k) number K252390.

Who is the listed applicant for Telescope Guide Extension Catheter?

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

What is the FDA product code for Telescope Guide Extension Catheter?

The FDA product code for Telescope Guide Extension Catheter is DQY.

其他以 Medtronic, Ireland 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。

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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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