5ed1a92c-1640-4433-9ece-b883f7502c48UpdatePublished42019-08-092016-09-22In Commercial Distribution05391518030890PrimaryGS1Tersus -14 BTKBTK25220S 985021909CREAGH MEDICAL LIMITED1Tersus-14 BTK25220S 2.5mm x 220mm x 120cm
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