ASAHI PTCA GUIDE WIRE, X-TREME

ASAHI PTCA GUIDE WIRE, X-TREME is an FDA 510(k)-cleared medical device (K072431) 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 25, 2007. Regulation: 8.