
Biosense Webster, Inc.
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CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES is an FDA 510(k)-cleared medical device (K093455) 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 December 3, 2009. Regulation: 8.