510(k) K965132

HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES by Mallinckrodt Medical — Product Code BTR

K965132 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on March 20, 1997. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.