CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is an FDA 510(k)-cleared medical device (K173977) 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 June 13, 2018. Regulation: 8.