ELM PTA Balloon Dilatation Catheter

ELM PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K143561) manufactured by O'Connell Regulatory Consultants, 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 May 18, 2015. Regulation: 8.