CARTO® 3 EP Navigation System with Signal Processing Unit

CARTO® 3 EP Navigation System with Signal Processing Unit is an FDA 510(k)-cleared medical device (K200484) 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 November 24, 2020. Regulation: 8.