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The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer a selective technique of temporary vascular occlusion, which is useful in selectively stopping blood flow in a vessel. The ev3 Occlusion Balloon Catheters may also be used in balloonassisted embolization of intracranial aneurysms.

The ev3 Occlusion Balloon Catheters are single lumen, open-ended balloon catheters designed for advancement into the vasculature over a 0.010" guidewire. Balloon inflation is accomplished by advancement of the guidewire through the open distal end of the balloon, redirecting inflation media to the balloon through side holes in the catheter wall.

The Occlusion Balloon Catheters are available in diameters ranging from 3 to 7 mm and lengths ranging from 7 to 30 mm.

The devices are packaged in a sterile pouch and are intended for single use only.

The provided text is for a medical device (Occlusion Balloon Catheters) and states explicitly that no nonclinical, clinical, or animal data were included in this submission. Therefore, no acceptance criteria or study data demonstrating device performance are available in the provided document.

The submission is for a 510(k) for an Occlusion Balloon Catheter, which relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than new clinical or performance data for the device itself.

Given this, I cannot provide the requested information about acceptance criteria and study details for this specific submission as it is not present in the provided text.

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