510(k) K181828

Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile by Scientia Vascular, LLC — Product Code MOF

K181828 is an FDA 510(k) premarket notification submitted by Scientia Vascular, LLC for the device "Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile". The FDA issued a decision of Substantially Equivalent on August 7, 2018. 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.