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Abbott Vascular-Cardiac Therapies
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VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER is an FDA 510(k)-cleared medical device (K103153) 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 December 29, 2010. Regulation: 8.