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MicroVention, Inc.
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HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS is an FDA 510(k)-cleared medical device (K080666) manufactured by MicroVention, 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 July 10, 2008. Regulation: 8.