REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR— 510(k) K011098

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K011098 for REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR, Substantially Equivalent on 2001-05-04. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2001-04-11
Decision date: 2001-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.