40ef98cd-c98b-4cf1-be04-13a31dafc146UpdatePublished32023-08-072019-10-20In Commercial Distribution00763000240318PrimaryGS1Chocolate®CB1413535120OTW006261481MEDTRONIC, INC.1PTA CB1413535120 CHOCOLATE 014 V02falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)633-8766Corporate.UDI@medtronic.comK13041400017184Peripheral 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, transluminalBalloon DiameterLengthDevice Size Text, specify5 F Recommended Sheath SizeBalloon LengthDevice Size Text, specify.014 IN Maximum Guidewire DiameterSpecial Storage Condition, SpecifyStore in a dry, cool place.truefalse