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Quick-Cross® Extreme Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Spectranetics Quick-Cross® Extreme Support Catheters are intravascular catheters. These catheters are available in a variety of lengths, diameters and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating on the distal 100cm for catheters with a working length greater than 100cm and 60cm for those with a working length less than 100cm

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study that validates the device against such criteria. The document is a 510(k) submission for a Quick-Cross Extreme Support Catheter, primarily focusing on its substantial equivalence to previously approved predicate devices.

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