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Coeur Medical
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THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 is an FDA 510(k)-cleared medical device (K032920) manufactured by Coeur Medical. 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 15, 2003. Regulation: 8.