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Creagh Medical, Ltd.
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ELM PTA BALLON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K113468) manufactured by Creagh Medical, 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 December 19, 2011. Regulation: 8.