
Usci Ireland
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OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K072156) manufactured by Usci Ireland. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2007. Regulation: 8.