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The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

The Daig Ultra-Flex Hemostasis Introducer is an Introducer designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Ultra-Flex Hemostasis Introducer), focusing on its substantial equivalence to a predicate device and its intended use. It does not include details on performance testing, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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