MIVI Q Distal Access Catheter

MIVI Q Distal Access Catheter is an FDA 510(k)-cleared medical device (K212402) manufactured by Mivi Neuroscience, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2021. Regulation: 8.