Device typeCoronary angioplasty balloon catheter, basic: A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.
FDA categoryCatheters, Transluminal Coronary Angioplasty, Percutaneous
Device ID04540778169616
Catalog numberDC-PY3720UA2
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
SizeMaximum Guidewire Diameter; 0.014 inch
SizeCompatible Guiding Catheter; 5 Fr
SizeRated Burst Pressure; 14 atm
SizeNominal Pressure; 6 atm
SizeProximal Shaft Diameter; 3.8 Fr
SizeDistal Shaft Diameter; 2.8 Fr
SizeCatheter Working Length; 1450 mm
SizeBalloon Length; 20 mm
SizeBalloon Diameter; 3.75 mm