9e228865-f9d6-4d57-ad7c-0d7d59bda379UpdatePublished32019-04-092018-05-12In Commercial Distribution08033477071909PrimaryGS1MO.MA ULTRAMUS0130069X6006261481MEDTRONIC, INC.1CATH MUS0130069X6 CPD ULTRA US 9F UL950falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK09217700058112Carotid artery embolic protection systemAn 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.falseActiveNTETemporary Carotid Catheter for Embolic CaptureDevice Size Text, specify0.083" Working Channel DiameterDevice Size Text, specify9F Minimum Recommended Introducer SheathSpecial Storage Condition, SpecifyStore at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).truefalse