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Micro Therapeutics, Inc.
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MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) is an FDA 510(k)-cleared medical device (K040694) manufactured by Micro Therapeutics, 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 March 24, 2004. Regulation: 8.