37b39557-a0ee-49f9-a6b8-f9a792f6e62cUpdatePublished32019-10-072016-09-24In Commercial Distribution08714729806387PrimaryGS1Emerge™H7493918920400021717889BOSTON SCIENTIFIC CORPORATION1PTCA Dilatation CatheterfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse47732Coronary 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, specify4.00 mm DiameterDevice Size Text, specify20 mm Lengthtruefalse