Confirm Rx Insertable Cardiac Monitor— 510(k) K182981

Substantially Equivalent

Abbott

FDA 510(k) clearance K182981 for Confirm Rx Insertable Cardiac Monitor, Substantially Equivalent on 2019-03-29. Applicant: Abbott.

Clearance details

Applicant: Abbott
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2018-10-29
Decision date: 2019-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, 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.