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Cordis Europa, N.V.
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CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA is an FDA 510(k)-cleared medical device (K032737) manufactured by Cordis Europa, N.V.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2003. Regulation: 8.