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Stryker Instruments, Instruments Div.
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IVAS 20MM (10 GAUGE) BALLOON CATHETER is an FDA 510(k)-cleared medical device (K113477) manufactured by Stryker Instruments, Instruments Div.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2012. Regulation: 8.