510(k) K160694

Disposable Endotracheal tube, sterile, AccuCuff by Tianjin Medis Medical Device Co., Ltd. — Product Code BTR

K160694 is an FDA 510(k) premarket notification submitted by Tianjin Medis Medical Device Co., Ltd. for the device "Disposable Endotracheal tube, sterile, AccuCuff". The FDA issued a decision of Substantially Equivalent on April 7, 2017. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Tianjin Medis Medical Device Co., Ltd. has at least 2 other 510(k) clearances on record.