CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module is an FDA 510(k)-cleared medical device (K173978) 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 August 23, 2018. Regulation: 8.