510(k) K252593

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

K252593 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.