510(k) K260537

Willow 24 Guidewire by Arbor Endovascular, LLC — Product Code MOF

K260537 is an FDA 510(k) premarket notification submitted by Arbor Endovascular, LLC for the device "Willow 24 Guidewire". The FDA issued a decision of Substantially Equivalent on March 19, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Arbor Endovascular, LLC has at least 3 other 510(k) clearances on record.