f61b3028-00de-4776-af6b-a54cd8115e10UpdatePublished42019-08-092016-09-22In Commercial Distribution05391518031484PrimaryGS1ELM HP PTAELM720S985021909CREAGH MEDICAL LIMITED1ELM HP PTA 7mm x 20mm x 40cm
falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK10264500017184Peripheral 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, TransluminalDQYCatheter, PercutaneousLengthOuter Diametertruefalse