0.014” Willow Guidewire

0.014” Willow Guidewire is an FDA 510(k)-cleared medical device (K253168) manufactured by Arbor Endovascular, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 2025. Regulation: 8.