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Abbott Vascular-Cardiac Therapies
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HI-TORQUE POWERTURN is an FDA 510(k)-cleared medical device (K112957) manufactured by Abbott Vascular-Cardiac Therapies. 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 7, 2011. Regulation: 8.