510(k) K051416

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA by Mallinckrodt Medical — Product Code JOH

K051416 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA". The FDA issued a decision of Substantially Equivalent on June 16, 2005. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.