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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, as well as compares its indications for use with predicate devices. It is a summary of safety and effectiveness, likely from a regulatory submission, but it lacks the specific details requested regarding performance studies.

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