QXMEDICAL ACCESS & SUPPORT CATHETER

QXMEDICAL ACCESS & SUPPORT CATHETER is an FDA 510(k)-cleared medical device (K123311) 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 January 13, 2013. Regulation: 8.