510(k) K201760

Zoom 14 Guidewire by Scientia Vascular, LLC — Product Code DQX

K201760 is an FDA 510(k) premarket notification submitted by Scientia Vascular, LLC for the device "Zoom 14 Guidewire". The FDA issued a decision of Substantially Equivalent on July 29, 2020. 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.