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The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.

exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

This document is a 510(k) summary for a medical device (exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft) and therefore does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML powered device. The information provided is for a traditional medical device (vascular graft) and focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing.

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