CARTO 3 EP Navigation System, Version 6.0 and Accessories

CARTO 3 EP Navigation System, Version 6.0 and Accessories is an FDA 510(k)-cleared medical device (K170600) 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 24, 2017. Regulation: 8.