Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 is an FDA 510(k)-cleared medical device (K192019) manufactured by ABBOTT MEDICAL. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 2019. Regulation: 8.