Device typePeripheral angioplasty balloon catheter, drug-coated: A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.
FDA categoryDrug-coated peripheral transluminal angioplasty catheter
Device ID00801741187803
Catalog numberLX351001260V
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
SizeBalloon Diameter, 12 Millimeter
SizeCatheter Length, 100 Centimeter
SizeBalloon Length, 60 Millimeter