Posted: September 10, 2018 |
Amsino’s Sure-Lok® Needle-free Connector Receives FDA 510(k) Clearance
Pomona, Ca — Amsino Medical Group Ltd. is pleased to announce that its new Sure-Lok needle-free connector has received United States Food and Drug Administration (FDA) 510(k) clearance as an Intravascular Administration Set, Class II device for I.V. administration applications. This new clearance allows Amsino to increase its product reach, further deepening the company’s overall I.V. medication delivery global platform.
Regarding the new product’s FDA 510(k) approval Dr. Richard Y. Lee, stated “We are excited to offer the enhanced safety technology of the Sure-Lok needle-free systems to our global customers to achieve even better and safer clinical results.”
The latest addition to the AMSafe® Medication Delivery Systems product line, the Sure-Lok needle-free connector provides infection control technology that has been industry recognized to help reduce bacterial contamination. The Sure-Lok’s clear housing provides a visual fluid flush confirmation with an improved flow-rate over other needle-free connectors of >200 mL/minute. Designed for easy connection and disconnection, the Sure-Lok has a lower resistance to luer connections., Its flat top, tight and smooth septum seal has been shown to help support effective disinfection. The new Sure-Lok needle-free connector is a perfect complement to the comprehensive AMSafe product portfolio that prioritizes safety first.
Amsino is dedicated to improving and strengthening the health and well-being of people around the world. With its advanced design the new Sure-Lok needle-free connector is a clear demonstration of Amsino’s commitment to globally improve safety in the healthcare industry.
Amsino’s superior quality, stringent production processes and technological advancements have gained the trust of healthcare professionals worldwide. With 25 years of experience, our goal is to not only meet industry expectations but exceed them. Our commitment to improving patient care is not only reflected in our products, but in our strong customer relationships as well.
Established in the U.S. in 1993, Amsino develops, manufactures and markets medical products that help improve the safety and effectiveness of patient care under a portfolio of recognized Amsino brands. We operate several U.S. FDA qualified manufacturing and R&D facilities in China, as well as corporate offices in California, with a total headcount of approximately 2,000.