510(k) K182861

Shiley Neonatal/Pediatric Tracheostomy Tube by Covidien — Product Code JOH

K182861 is an FDA 510(k) premarket notification submitted by Covidien for the device "Shiley Neonatal/Pediatric Tracheostomy Tube". The FDA issued a decision of Substantially Equivalent on March 22, 2019. 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.