EnSite Precision Cardiac Mapping System v2.0

EnSite Precision Cardiac Mapping System v2.0 is an FDA 510(k)-cleared medical device (K160210) manufactured by St Jude 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 December 12, 2016. Regulation: 8.