510(k) K183608

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile by Scientia Vascular, LLC — Product Code MOF

K183608 is an FDA 510(k) premarket notification submitted by Scientia Vascular, LLC for the device "Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile". The FDA issued a decision of Substantially Equivalent on March 22, 2019. 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.