STRYKER IVAS BALLOON CATHETER

STRYKER IVAS BALLOON CATHETER is an FDA 510(k)-cleared medical device (K123942) manufactured by Stryker Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 2, 2013. Regulation: 8.