510(k) K210608

LUX-Dx Insertable Cardiac Monitor by Boston Scientific Corporation — Product Code MXD

K210608 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "LUX-Dx Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on May 25, 2021. 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.