CARTO™ 3 EP Navigation System V9.0 with PIU Plus

CARTO™ 3 EP Navigation System V9.0 with PIU Plus is an FDA 510(k)-cleared medical device (K254085) 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 January 17, 2026. Regulation: 8.