Device typePeripheral angioplasty balloon catheter, basic: A 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.
FDA categoryCatheter, Angioplasty, Peripheral, Transluminal
Device ID05391525783932
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Balloon Diameter4.0 Millimeter
Balloon Length80 Millimeter
Catheter Length250 Centimeter
SizeGuidewire Compatibility: 0.014 Inch