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Cardiac Assist Devices, Inc.
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GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E is an FDA 510(k)-cleared medical device (K012520) manufactured by Cardiac Assist Devices, 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 March 26, 2002. Regulation: 8.