Pruitt F3-S Polyurethane Carotid Shunt

Pruitt F3-S Polyurethane Carotid Shunt is an FDA 510(k)-cleared medical device (K152833) manufactured by LeMaitre Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2016. Regulation: 8.