K243928

Substantially Equivalent

ViaOne Epicardial Access System

Applicant: Cardiovia , Ltd.
Product code: DYB
Advisory panel: Cardiovascular
Date received: 2024-12-20
Decision date: 2025-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.