Passeo-35 PTA Catheter

Passeo-35 PTA Catheter is an FDA 510(k)-cleared medical device (K142379) manufactured by Biotronik, 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 December 4, 2014. Regulation: 8.