PolarCath Peripheral Dilatation System

PolarCath Peripheral Dilatation System is an FDA 510(k)-cleared medical device (K152665) manufactured by Nucyro Vascular, 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 October 25, 2015. Regulation: 8.