ANGIOJET ULTRA POWER PULSE KIT

ANGIOJET ULTRA POWER PULSE KIT is an FDA 510(k)-cleared medical device (K130381) manufactured by Medrad, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2013. Regulation: 8.