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ICU Medical needleless connector receives 510(k) clearance

This article was originally published in The Gray Sheet

Executive Summary

Neutron neutral-pressure needleless connector is designed to prevent all types of blood reflux in a catheter, including line and syringe disconnection, patient vascular pressure changes caused by coughing or sneezing, as well as an IV bag running dry, the firm said Aug. 3. According to ICU Medical, the neutral-pressure design may help address FDA concerns about the safety of positive displacement needleless connectors. The agency recently said it would require nine companies - including ICU - to conduct post-market surveillance studies on their connectors to determine if they are associated with higher rates of device-associated bloodstream infections (1"The Gray Sheet" Aug. 2, 2010)
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