
Biosense Webster, Inc.
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CARTO XP EP NAVIGATION SYSTEM, VERSION 9 is an FDA 510(k)-cleared medical device (K070240) 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 May 3, 2007. Regulation: 8.