
Abbott Vascular
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HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 is an FDA 510(k)-cleared medical device (K083738) manufactured by Abbott Vascular. 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 10, 2009. Regulation: 8.