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The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic arteriovenous dialysis fistulae.

The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.

This document is a 510(k) premarket notification for a medical device called the "2 cm Peripheral Cutting Balloon™". It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI/algorithm-based device.

The document discusses substantial equivalence to predicate devices based on design, fundamental technology, intended use, and general performance and biocompatibility testing. It's a regulatory document for a physical medical device, not a software or AI-based diagnostic tool.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text.

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