Covidien Receives FDA Clearance for Mallinckrodt TaperGuard Evac Endotracheal Tube
December 22, 2009 by Beckers ASC Review
Filed under Becker's ASC Review, Industry Updates
Covidien, a global provider of healthcare products and an innovator in mechanical ventilation and respiratory care devices, received 510(k) clearance from the U.S. Food and Drug Administration to market its Mallinckrodt TaperGuard Evac endotracheal tube, according to a Covidien news release.
The TaperGuard endotracheal tube reduces leakage past the cuff by at least 81 percent compared with the Mallinckrodt Hi-Lo endotracheal tube, potentially reducing the risk of post-surgical complications that may be caused by aspiration of fluids into the lungs, according to the report.
“The TaperGuard endotracheal tubes offer significant advantages for anesthesiologists, surgeons and their patients,” Jim Willett, general manager and vice president of airway and ventilation for Covidien, said in the report. “This FDA 510(k) clearance means more physicians will gain awareness of this innovative product and incorporate its use into their procedures, confirming Covidien’s mission to provide solutions designed to improve patient safety, medical efficacy and healthcare efficiency.”
Read the Covidien release about Mallinckrodt TaperGuard Evac Endotracheal Tubes.
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A post by "Becker's ASC Editor" http://www.beckersasc.com Becker's ASC Review is a bimonthly publication that offers general business, legal and clinical guidance on topics including joint-ventures, development and expansion, and regulatory and compliance issues. |
