
Ostial Corporation
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FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM is an FDA 510(k)-cleared medical device (K121175) manufactured by Ostial Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2012. Regulation: 8.