CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 is an FDA 510(k)-cleared medical device (K223733) 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 February 15, 2023. Regulation: 8.