CARTO 3 EP Navigation System Version 7.2

CARTO 3 EP Navigation System Version 7.2 is an FDA 510(k)-cleared medical device (K213264) manufactured by Biosense Webster, 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 October 28, 2021. Regulation: 8.