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Angioscore, Inc.
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ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 is an FDA 510(k)-cleared medical device (K080151) manufactured by Angioscore, 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 24, 2008. Regulation: 8.