510(k) K160542

5.0 Fr Arndt Endobronchial Blocker Set by Cook Incorporated — Product Code CBI

K160542 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "5.0 Fr Arndt Endobronchial Blocker Set". The FDA issued a decision of Substantially Equivalent on August 2, 2016. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Cook Incorporated has at least 10 other 510(k) clearances on record.