Advance 14LP Low Profile PTA Balloon Dilatation Catheter

Advance 14LP Low Profile PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K170193) manufactured by Cook Incorporated. 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.