IVAS 10MM AND 15MM BALLOON CATHETER

IVAS 10MM AND 15MM BALLOON CATHETER is an FDA 510(k)-cleared medical device (K130430) 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 May 22, 2013. Regulation: 8.