Serranator Alto PTA Serration Balloon Catheter

Serranator Alto PTA Serration Balloon Catheter is an FDA 510(k)-cleared medical device (K163380) manufactured by Cagent 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 February 12, 2017. Regulation: 8.