510(k) K192558

Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter by Mivi Neurovascular — Product Code DQY

K192558 is an FDA 510(k) premarket notification submitted by Mivi Neurovascular for the device "Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter". The FDA issued a decision of Substantially Equivalent on April 6, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Mivi Neurovascular has at least 1 other 510(k) clearance on record.