(144 days)
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.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).