ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300

ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300 is an FDA 510(k)-cleared medical device (K032615) 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 September 15, 2003. Regulation: 8.