Device typeCarotid artery embolic protection system: An assembly of devices intended to provide cerebrovascular embolic protection during carotid artery angioplasty and stenting procedures. It is available in various configurations and typically includes a sheath/catheter(s), intravascular balloon(s), guidewire, and extracorporeal valves/filters. The assembly is introduced into an artery percutaneously and used to produce blockage of blood through balloon inflation, typically at the carotid bifurcation and internal carotid artery to prevent distal embolization by particulate debris/thrombus and allow removal of debris/thrombus by blood filtration or aspiration. This is a single-use device.
FDA categoryTemporary Carotid Catheter for Embolic Capture
Device ID08033477071909
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size"0.083"" Working Channel Diameter"
Size9F Minimum Recommended Introducer Sheath