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 ID00763000500153
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Length150.0 Centimeter
Balloon Length40.0 Millimeter
Size5 F Recommended Sheath Size
Balloon Diameter3.0 Millimeter
Size.014 IN Maximum Guidewire Diameter