FDA 510(k)

AcQMap 3D 影像與地圖導管

K 號：K201341 · 2020-09-15

決定日期2020-09-15

產品代碼MTD

諮詢委員會履歷

決定相當於

器材摘要

AcQMap 3D Imaging and Mapping Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K201341. 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 AcQMap 3D Imaging and Mapping Catheter?

AcQMap 3D Imaging and Mapping Catheter is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K201341.

When did AcQMap 3D Imaging and Mapping Catheter receive FDA 510(k) clearance?

AcQMap 3D Imaging and Mapping Catheter received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201341.

Who is the listed applicant for AcQMap 3D Imaging and Mapping Catheter?

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

What is the FDA product code for AcQMap 3D Imaging and Mapping Catheter?

The FDA product code for AcQMap 3D Imaging and Mapping Catheter is MTD.

其他以 Acutus Medical, Inc. 為申請人之記錄

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K233691FlexCath 過隔膜解決方案 K231091AcQMap 高解析度影像與地圖系統 K230606AcQMap® 高解析度影像與地圖系統 K222209AcQMap 高解析度影像與地圖系統 K220784AcQMap 高解析度影像與地圖系統 K210766AcQMap 3D 影像與地圖導管，型號 900009

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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。

K261012OptiMap 管子 - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap 管子 - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433球體-9Dx 診斷導管 (AFR-00009)Medtronic K241372Advisor™ HD 格子 X 映射導管，感測器啟用™ABBOTT MEDICAL K231312PENTARAY® NAV ECO 高密度地圖導管，DECANAV® 地圖導管，帶有自動識別功能的 Webster® CS 領管，帶有 EZ Steer 技術的 Webster® CS 領管，帶有自動識別功能的 EZ Steer 技術 Webster® CS 領管Biosense Webster, Inc.K223666Ablacath™ 繪製導管Ablacon, Inc.

官方來源

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