Vesalio Peripheral System— 510(k) K251312

Substantially Equivalent

Vesalio, Inc.

FDA 510(k) clearance K251312 for Vesalio Peripheral System, Substantially Equivalent on 2025-10-24. Applicant: Vesalio, Inc..

Clearance details

Applicant: Vesalio, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2025-04-28
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.