CARTO 3 EP Navigation System, Version 7.1 and Accessories

CARTO 3 EP Navigation System, Version 7.1 and Accessories is an FDA 510(k)-cleared medical device (K191660) 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 July 19, 2019. Regulation: 8.