c-med0 alpha— 510(k) K253436

Substantially Equivalent

Cosinuss GmbH

FDA 510(k) clearance K253436 for c-med0 alpha, Substantially Equivalent on 2026-04-30. Applicant: Cosinuss GmbH.

Clearance details

Applicant: Cosinuss GmbH
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2025-10-01
Decision date: 2026-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.