
Biosense Webster, Inc.
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CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) is an FDA 510(k)-cleared medical device (K072202) 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 November 18, 2007. Regulation: 8.