510(k) K153761

Emergency Transtracheal Airway Catheter by Cook Incorporated — Product Code BWC

K153761 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Emergency Transtracheal Airway Catheter". The FDA issued a decision of Substantially Equivalent on September 22, 2016. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. Cook Incorporated has at least 10 other 510(k) clearances on record.