LINQ II Insertable Cardiac Monitor— 510(k) K211304

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K211304 for LINQ II Insertable Cardiac Monitor, Substantially Equivalent on 2021-05-28. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code MXD
Advisory panel: Cardiovascular
Date received: 2021-04-29
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Special
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.