REVEAL PLUS INSERTABLE LOOP RECORDER— 510(k) K003667

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K003667 for REVEAL PLUS INSERTABLE LOOP RECORDER, Substantially Equivalent on 2001-02-14. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2000-11-28
Decision date: 2001-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
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.