CSF-4 (CSF-4)— 510(k) K232445

Substantially Equivalent

Cardiacsense

FDA 510(k) clearance K232445 for CSF-4 (CSF-4), Substantially Equivalent on 2024-05-02. Applicant: Cardiacsense.

Clearance details

Applicant: Cardiacsense
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2023-08-14
Decision date: 2024-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.