510(k) K254181

Aristotle 65 Macrowire by Scientia Vascular — Product Code MOF

K254181 is an FDA 510(k) premarket notification submitted by Scientia Vascular for the device "Aristotle 65 Macrowire". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Scientia Vascular has at least 10 other 510(k) clearances on record.