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The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts.

The Vesseal is a hand-held device, enabling simultaneous deployment of 8 double-armed 9-0 to 7-0 nylon sutures (USP certified). The sutures are delivered from the inside out, around the circumference of two ends of blood vessels (ranging in size from 2mm to 4mm) to assist in the creation of a microvascular anastomosis. The Vesseal is comprised of two main mechanisms: 1. The needle insertion mechanism contains two rod protrusions, intended for locating the blood vessel, opening, mounting, and positioning them relative to the stopper mechanism. Each rod stores, 8 curved needles that allow the transition of the double-armed nylon sutures during deployment. 2. The handle deployment mechanism features right and left switches to deploy the needles on the respective rod side, and the gear to rotate the rod and enable access to its entire perimeter.

The given text is a 510(k) summary for the medical device "Vesseal". There is no mention of acceptance criteria or a study that proves the device meets acceptance criteria. The document describes the device, its intended use, comparison to predicate devices, and the types of performance data used to support substantial equivalence.

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