510(k) K003315

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA by Mallinckrodt, Inc. — Product Code JOH

K003315 is an FDA 510(k) premarket notification submitted by Mallinckrodt, Inc. for the device "SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA". The FDA issued a decision of Substantially Equivalent on November 8, 2000. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Mallinckrodt, Inc. has at least 1 other 510(k) clearance on record.