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Volcano Therapeutics, Inc.
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COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE is an FDA 510(k)-cleared medical device (K042996) manufactured by Volcano 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 November 23, 2004. Regulation: 8.