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510(k) K252593

LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) by Boston Scientific Corporation — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
August 15, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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