321bcbff-16a3-4066-9be9-deb0b782c560NewPublished12019-07-302019-07-22In Commercial DistributionB38010FCES150PrimaryHIBCCCAROTID ENDARTERECTOMY SHUNT10FCES15878198993LUCAS MEDICAL INC1falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety InformationtruefalseK98380200047113Carotid artery shuntA sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.falseActiveMJNCatheter, Intravascular Occluding, TemporarytruetrueEthylene Oxide