Viradius Neurowire— 510(k) K151825

Substantially Equivalent

Mivi Neuroscience, Inc.

FDA 510(k) clearance K151825 for Viradius Neurowire, Substantially Equivalent on 2015-11-16. Applicant: Mivi Neuroscience, Inc..

Clearance details

Applicant: Mivi Neuroscience, Inc.
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2015-07-06
Decision date: 2015-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prarie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MOF

product code MOF

Death: 6
Injury: 137
Total: 143

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.