510(k) K150844

Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula by Covidien — Product Code JOH

K150844 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula". The FDA issued a decision of Substantially Equivalent on July 14, 2015. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Covidien has at least 10 other 510(k) clearances on record.