510(k) K142298

Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff by Covidien — Product Code JOH

K142298 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff". The FDA issued a decision of Substantially Equivalent on Feb 13, 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.