510(k) K243938

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire by Scientia Vascular, Inc. — Product Code MOF

K243938 is an FDA 510(k) premarket notification submitted by Scientia Vascular, Inc. for the device "Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire". The FDA issued a decision of Substantially Equivalent on April 1, 2025. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Scientia Vascular, Inc. has at least 10 other 510(k) clearances on record.