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Endocross, Ltd.
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ENABLER-P CATHETER SYSTEM, MODEL 3000 is an FDA 510(k)-cleared medical device (K092174) manufactured by Endocross, 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 29, 2009. Regulation: 8.