510(k) K871204

CUFFED TRACHEAL TUBE (MULTIPLE) by Mallinckrodt Critical Care — Product Code BTR

K871204 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "CUFFED TRACHEAL TUBE (MULTIPLE)". The FDA issued a decision of Substantially Equivalent on April 21, 1987. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.