
Abbott Vascular-Cardiac Therapies
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HI-TORQUE BALANCE MIDDLEWEIGHT ELITE is an FDA 510(k)-cleared medical device (K103101) 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 February 9, 2011. Regulation: 8.