Fogarty Arterial Embolectomy Catheter with Gate Valve

Fogarty Arterial Embolectomy Catheter with Gate Valve is an FDA 510(k)-cleared medical device (K233820) manufactured by Edwards Lifesciences. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2024. Regulation: 8.