510(k) K801005

MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) by National Catheter Co. Div. Mallinckrodt — Product Code BTR

K801005 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)". The FDA issued a decision of Substantially Equivalent on May 23, 1980. 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.