510(k) K011098

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR by Medtronic Vascular — Product Code MXC

K011098 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800. Medtronic Vascular has at least 10 other 510(k) clearances on record.