Athletis PTA Balloon Dilatation Catheter

Athletis PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K201170) manufactured by Boston Scientific 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 September 14, 2020. Regulation: 8.