510(k) K971267

SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF by Mallinckrodt Medical — Product Code JOH

K971267 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF". The FDA issued a decision of Substantially Equivalent on September 25, 1997. 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.