K253168

Substantially Equivalent

0.014 Willow Guidewire

Applicant: Arbor Endovascular, LLC
Product code: MOF
Advisory panel: Cardiovascular
Date received: 2025-09-26
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

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.