510(k) K230553

LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application by Medtronic, Inc. — Product Code MXD

K230553 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application". The FDA issued a decision of Substantially Equivalent on April 26, 2023. The device falls under product code MXD (Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.1025. Medtronic, Inc. has at least 10 other 510(k) clearances on record.