Device typeCoronary angioplasty balloon catheter, drug-coated: A flexible tube with a drug coating at its distal end designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate an atherosclerotic stenotic coronary artery by controlled inflation of a distal distensible balloon, and to simultaneously release a drug intended to inhibit restenosis. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. It may be available as an over-the-wire (OTW) or a rapid exchange (RX) type, and devices to assist catheterization may be included. This is a single-use device.
FDA categoryDrug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
Device ID00810220870242
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Balloon Diameter3.00 Millimeter
Balloon Length15 Millimeter