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The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The device consists of a double-lumen catheter with a non-compliant balloon attached at the distal tip. One of the lumens connects the Y-Adaptor to the proximal end of the outer shaft and the other connects the Y-Adaptor wire port extending from the wire lumen to the distal end of the balloon. The outer lumen is the balloon inflation lumen and is used to inflate and deflate the balloon during the procedure. The inner lumen is used to pass the catheter over a guidewire. The product is intended to pass a 0.018" (0.46 mm) guidewire. The catheter useable length (effective length) is measured from the distal end of the strain relief to the tip and is available in three sizes - 50 cm, 90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The device is coated with MDX 4-4159 silicone coating.