510(k) K193119

Twin-Pass Dual Access Catheter by Vascular Solutions, LLC — Product Code DQY

K193119 is an FDA 510(k) premarket notification submitted by Vascular Solutions, LLC for the device "Twin-Pass Dual Access Catheter". The FDA issued a decision of Substantially Equivalent on June 29, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Vascular Solutions, LLC has at least 10 other 510(k) clearances on record.