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Velocimed
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PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 is an FDA 510(k)-cleared medical device (K023548) manufactured by Velocimed. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 3, 2003. Regulation: 8.