Cronus HP - High Pressure Peripheral Balloon Catheter

Cronus HP - High Pressure Peripheral Balloon Catheter is an FDA 510(k)-cleared medical device (K151141) manufactured by Nipro Medical Corporation. 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, 2016. Regulation: 8.