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Cordis Neurovascular, Inc.
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TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION is an FDA 510(k)-cleared medical device (K053197) manufactured by Cordis Neurovascular, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2005. Regulation: 8.