
Asahi Intecc Co., Ltd.
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ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY is an FDA 510(k)-cleared medical device (K060745) 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 June 22, 2006. Regulation: 8.