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Qxmedical, LLC
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Q50 PLUS STENT GRAFT BALLOON CATHETER is an FDA 510(k)-cleared medical device (K120381) manufactured by Qxmedical, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 23, 2012. Regulation: 8.