Assert-IQ Insertable Cardiac Monitor— 510(k) K230286

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K230286 for Assert-IQ Insertable Cardiac Monitor, Substantially Equivalent on 2023-05-17. Applicant: ABBOTT MEDICAL.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code MXC
Advisory panel: Cardiovascular
Date received: 2023-02-02
Decision date: 2023-05-17
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.