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Angioslide, Ltd.
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PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE is an FDA 510(k)-cleared medical device (K120805) manufactured by Angioslide, Ltd.. 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 12, 2012. Regulation: 8.