
MicroVention, Inc.
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HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) is an FDA 510(k)-cleared medical device (K091641) 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 June 29, 2009. Regulation: 8.