7e4c4d89-a0ad-435d-ab8f-cdbda30facd0UpdatePublished22025-11-242025-04-14In Commercial Distribution06942265509727PrimaryGS1Parafleet SC 018 PTA Balloon Dilatation Catheterrev 01F18-040200-090421318800BrosMed Medical Co.,Ltd.1falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse17184Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.falseActiveLITCatheter, Angioplasty, Peripheral, Transluminaltruefalse