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Asahi Intecc Co., Ltd.
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ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE is an FDA 510(k)-cleared medical device (K103057) manufactured by Asahi Intecc Co., Ltd.. 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 18, 2010. Regulation: 8.