ASC BALANCE MIDDLEWEIGHT GUIDE WIRE

ASC BALANCE MIDDLEWEIGHT GUIDE WIRE is an FDA 510(k)-cleared medical device (K971815) manufactured by Guidant Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 1997. Regulation: 8.