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Micro Therapeutics, Inc.
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EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 is an FDA 510(k)-cleared medical device (K010162) manufactured by Micro Therapeutics, 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 May 17, 2001. Regulation: 8.