b89f479c-2320-4534-8e2f-0cb0a6cdb847NewPublished12021-09-282021-09-20In Commercial Distribution06971591765804PrimaryGS1Selethru NC PTCA Balloon Dilatation CatheterKNC250030560219894Kossel Medtech (Suzhou) Co., Ltd.1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK21139300017521Coronary angioplasty balloon catheter, perfusingA sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blood flow to the distal coronary arteries during balloon dilatation to protect the myocardium from haemodynamic compromise. This is a single-use device.falseActiveLOXCatheters, Transluminal Coronary Angioplasty, Percutaneoustruefalse