6f1e560c-3491-43e3-b480-7585416c51eaUpdatePublished42019-04-092016-05-082018-10-05Not in Commercial Distribution08033477034294PrimaryGS1FiberNetFBC500600190006261481MEDTRONIC, INC.1Cath FBC500600190 FBC SW 5.0-6.0 UL1900falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.com44841Embolic protection filtering guidewireA steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.falseActiveNTETemporary Carotid Catheter for Embolic CaptureDevice Size Text, specify5.0-6.0 MM Recommended Vessel DiameterLengthSpecial Storage Condition, SpecifyStore at controlled room temperature, in a dry place. Keep away from sunlight.truefalse