EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System is an FDA 510(k)-cleared medical device (K201181) 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 June 25, 2020. Regulation: 8.