EDWARDS PERIPHERAL DILATATION CATHETER

EDWARDS PERIPHERAL DILATATION CATHETER is an FDA 510(k)-cleared medical device (K032587) manufactured by Edwards Lifesciences, 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 October 1, 2003. Regulation: 8.