510(k) K192454

Wattson Temporary Pacing Guidewire by Vascular Solutions — Product Code DQX

K192454 is an FDA 510(k) premarket notification submitted by Vascular Solutions for the device "Wattson Temporary Pacing Guidewire". The FDA issued a decision of Substantially Equivalent on January 15, 2020. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Vascular Solutions has at least 10 other 510(k) clearances on record.