Willow 18 Guidewire— 510(k) K260130

Substantially Equivalent

Arbor Endovascular, LLC

FDA 510(k) clearance K260130 for Willow 18 Guidewire, Substantially Equivalent on 2026-02-13. Applicant: Arbor Endovascular, LLC.

Clearance details

Applicant: Arbor Endovascular, LLC
Product code: Code MOF
Advisory panel: Cardiovascular
Date received: 2026-01-16
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Special
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.