ddb39c34-11d6-41ca-a371-cfba707265d0NewPublished12022-12-202022-12-12In Commercial Distribution07640142572893PrimaryGS1OPN NC450-015-004483665555SIS Medical AG1OPN NC Ø4.5x15 PTCA catheters falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK21239300047732Coronary 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, PercutaneousStorage Environment TemperatureStorage Environment Temperaturetruefalse