Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe is an FDA 510(k)-cleared medical device (K193379) 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 June 11, 2020. Regulation: 8.