Device typeCoronary angioplasty balloon catheter, cutting/scoring: A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical atherotomes) intended to remove stenotic material. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. This is a single-use device.
FDA categoryCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Device ID00813132026875
Catalog number2200-3006-B
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Balloon Diameter3.0 Millimeter
Balloon Length06 Millimeter