FDA 510(k)

LINQ II™ 可植入式心臟監護器 (ICM)

K 號：K240693 · 2024-03-28

決定日期2024-03-28

產品代碼MXD

諮詢委員會履歷

決定相當於

器材摘要

LINQ II™ Insertable Cardiac Monitor (ICM) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240693. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LINQ II™ Insertable Cardiac Monitor (ICM)?

LINQ II™ Insertable Cardiac Monitor (ICM) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Medtronic, Inc.. The 510(k) number is K240693.

When did LINQ II™ Insertable Cardiac Monitor (ICM) receive FDA 510(k) clearance?

LINQ II™ Insertable Cardiac Monitor (ICM) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240693.

Who is the listed applicant for LINQ II™ Insertable Cardiac Monitor (ICM)?

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 LINQ II™ Insertable Cardiac Monitor (ICM)?

The FDA product code for LINQ II™ Insertable Cardiac Monitor (ICM) is MXD.

其他以 Medtronic, Inc. 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。

K262913Protégé™ EverFlex™ 自擴張週邊支架系統 K262735LINQ II 可植入式心臟監護器 (ICM) (LNQ22)K262005Affera 整合地圖系統 K261335VitalFlow Set with Balance™ 生物表面 K261866Concerto Versa™ 可拆式線圈 K260195延長式單件動脈（EOPA）3D™ 運動脈管

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相關器械（代碼：MXD）

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。

K262735LINQ II 可植入式心臟監護器 (ICM) (LNQ22)Medtronic, Inc.K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICAL K251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)Abbott K252593LUX-Dx II 可植入式心臟監護器（M302）；LUX-Dx II+ 可植入式心臟監護器（M312）Boston Scientific Corporation K233562LINQ II 可植入式心臟監護器Medtronic, Inc.

官方來源

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