0.014 Willow Guidewire— 510(k) K243756

Substantially Equivalent

Arbor Endovascular, LLC

FDA 510(k) clearance K243756 for 0.014 Willow Guidewire, Substantially Equivalent on 2025-07-17. Applicant: Arbor Endovascular, LLC.

Clearance details

Applicant: Arbor Endovascular, LLC
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2024-12-06
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.