FDA 510(k)

LUX-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）

K 號：K252593 · 2025-09-12

決定日期2025-09-12

產品代碼MXD

諮詢委員會履歷

決定相當於

器材摘要

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252593. 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 LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K252593.

When did LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) receive FDA 510(k) clearance?

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252593.

Who is the listed applicant for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)?

The FDA product code for LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) is MXD.

其他以 Boston Scientific Corporation 為申請人之記錄

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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 K240693LINQ II™ 可植入式心臟監護器 (ICM)Medtronic, Inc.K233562LINQ II 可植入式心臟監護器Medtronic, Inc.

官方來源

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