510(k) K860901

LASER RESISTANT TRACHEAL TUBE (TENTATIVE) by Mallinckrodt Critical Care — Product Code BTR

K860901 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "LASER RESISTANT TRACHEAL TUBE (TENTATIVE)". The FDA issued a decision of Substantially Equivalent on June 5, 1986. 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.