5cb97ab4-6f7d-41cc-8a27-2a84dc9232d5UpdatePublished92026-05-292017-02-03In Commercial Distribution07640130415744PrimaryGS1Pantera LEO2.75/15/145367016480862817Biotronik AG1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse612-423-1738FDA.US.Agent@teleflex.com47732Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.falseActiveLOXCatheters, transluminal coronary angioplasty, percutaneousDevice Size Text, specifyLength: 15 mmDevice Size Text, specifyUsable Length: 145 cmDevice Size Text, specifyDiameter: 2.75 mmStorage Environment TemperatureStorage Environment TemperatureSpecial Storage Condition, SpecifyKeep dry Keep away from sunlighttruefalse