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Ev3, Inc.
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EVERCROSS 0.035 OTW PTA DILATATION CATHETER is an FDA 510(k)-cleared medical device (K110319) manufactured by Ev3, 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 April 13, 2011. Regulation: 8.