510(k) K802505

DOUBLE LUMEN TRACHEAL TUBE by National Catheter Co. Div. Mallinckrodt — Product Code BTR

K802505 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "DOUBLE LUMEN TRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on March 13, 1981. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.