510(k) K142296

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

K142296 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula". The FDA issued a decision of Substantially Equivalent on February 24, 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.