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Stryker Corporation
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IVAS 2-10MM (10 GUAGE) BALLON CATHETER is an FDA 510(k)-cleared medical device (K103807) 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 June 27, 2011. Regulation: 8.