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Micro Therapeutics Dba Ev3 Neurovascular
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SOLITAIRE 2 REVASCULARIZATION DEVICE is an FDA 510(k)-cleared medical device (K123378) manufactured by Micro Therapeutics Dba Ev3 Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2012. Regulation: 8.