FDA 510(k)

Advisor™ HD 格子 X 映射導管，感測器啟用™

K 號：K241372 · 2024-07-09

決定日期2024-07-09

產品代碼MTD

諮詢委員會履歷

決定相當於

器材摘要

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2024-07-09 under 510(k) number K241372. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is a medical device that received FDA 510(k) clearance on 2024-07-09. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K241372.

When did Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ receive FDA 510(k) clearance?

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ received FDA 510(k) clearance on 2024-07-09, under 510(k) number K241372.

Who is the listed applicant for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

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

What is the FDA product code for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™?

The FDA product code for Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ is MTD.

其他以 ABBOTT MEDICAL 為申請人之記錄

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相關器械（代碼：MTD）

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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