ACUITY WHISPER VIEW GUIDE WIRES

ACUITY WHISPER VIEW GUIDE WIRES is an FDA 510(k)-cleared medical device (K110479) manufactured by Boston Scientific 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 April 7, 2011. Regulation: 8.