510(k) K192783

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile by Scientia Vascular, LLC — Product Code DQX

K192783 is an FDA 510(k) premarket notification submitted by Scientia Vascular, LLC for the device "Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile". The FDA issued a decision of Substantially Equivalent on October 30, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scientia Vascular, LLC has at least 10 other 510(k) clearances on record.