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 ID04540778155572
Catalog numberBD-L80040MW
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
SizeMaximum Guidewire Diameter; 0.035 inch
SizeCompatible Sheath Diameter; 6 Fr
SizeRated Burst Pressure; 14 atm
SizeNominal Pressure; 8 atm
SizeShaft Diameter; 5.7 Fr
SizeCatheter Working Length; 900 mm
SizeBalloon Length; 40 mm
SizeBalloon Diameter; 8.0 mm