510(k) K220398

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire by Scientia Vascular, LLC — Product Code MOF

K220398 is an FDA 510(k) premarket notification submitted by Scientia Vascular, LLC for the device "Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire". The FDA issued a decision of Substantially Equivalent on March 10, 2023. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Scientia Vascular, LLC has at least 10 other 510(k) clearances on record.