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Asahi Intecc USA, Inc.
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ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE is an FDA 510(k)-cleared medical device (K110553) manufactured by Asahi Intecc USA, 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 March 17, 2011. Regulation: 8.