LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application— 510(k) K230553

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K230553 for LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application, Substantially Equivalent on 2023-04-26. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code MXD
Advisory panel: Cardiovascular
Date received: 2023-02-28
Decision date: 2023-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

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.