Willow 18 Guidewire

Willow 18 Guidewire is an FDA 510(k)-cleared medical device (K260130) 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 February 12, 2026. Regulation: 8.