510(k) K202888

Confirm Rx Insertable Cardiac Monitor by Abbott (St. Jude Medical) — Product Code MXC

K202888 is an FDA 510(k) premarket notification submitted by Abbott (St. Jude Medical) for the device "Confirm Rx Insertable Cardiac Monitor". The FDA issued a decision of Substantially Equivalent on November 23, 2020. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. Abbott (St. Jude Medical) has at least 5 other 510(k) clearances on record.