754cbcb5-c77d-4451-b3ed-6d32f8cc039bUpdatePublished52021-12-062016-09-10In Commercial Distribution06958481413304PrimaryGS1Apollo Balloon Dilatation Catheterrev 01802-3218U421318800BrosMed Medical Co.,Ltd.1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse47732Coronary 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, Percutaneoustruefalse