26201b6a-f251-455b-92e0-bd89c8765feeNewPublished12024-03-182024-03-08In Commercial Distribution00763000757342PrimaryGS1NanoCross™ EliteAB14W020120150006261481MEDTRONIC, INC.1PTA AB14W020120150 NANOCROSS 014 V06falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK14111800017184Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.falseActiveLITCatheter, angioplasty, peripheral, transluminalDevice Size Text, specifyMinimum sheath inner diameter 4 FrBalloon LengthBalloon DiameterCatheter Working LengthSpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, SpecifyKeep drytruefalse