Fogarty Occlusion Catheter

Fogarty Occlusion Catheter is an FDA 510(k)-cleared medical device (K211610) 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 February 13, 2022. Regulation: 8.