MIVI Mi-AXUS Guide Catheter

MIVI Mi-AXUS Guide Catheter is an FDA 510(k)-cleared medical device (K151396) 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 8, 2015. Regulation: 8.