SmartCardia 7L Platform (MCT)— 510(k) K240653

Substantially Equivalent

Smartcardia SA

FDA 510(k) clearance K240653 for SmartCardia 7L Platform (MCT), Substantially Equivalent on 2024-10-31. Applicant: Smartcardia SA.

Clearance details

Applicant: Smartcardia SA
Product code: Code QYX
Advisory panel: Cardiovascular
Date received: 2024-03-07
Decision date: 2024-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lausanne, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code QYX

product code QYX

Death: 13
Malfunction: 526
Total: 539

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.