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Artegraft, Inc.
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D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 is an FDA 510(k)-cleared medical device (K083370) manufactured by Artegraft, Inc.. 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 11, 2008. Regulation: 8.