Search Results

The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.

I am unable to provide a description of acceptance criteria and a study proving device meets acceptance criteria, as the document does not contain information on device performance or clinical study results for the Sunmed™ Haemostatic Valves.

The document is a 510(k) premarket notification for a medical device (Sunmed™ Haemostatic Valves) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility. It explicitly states in section 8 that "Clinical Evaluation was not applicable." Therefore, there is no information about acceptance criteria for device performance or a study proving the device meets said criteria.

Ask a specific question about this device