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FDA 510(k)

Shiley Neonatal/Pediatric Tracheostomy Tube

K-Number: K182861 · 2019-03-22

ApplicantCovidien
Decision Date2019-03-22
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Shiley Neonatal/Pediatric Tracheostomy Tube is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2019-03-22 under approval number K182861. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shiley Neonatal/Pediatric Tracheostomy Tube?

Shiley Neonatal/Pediatric Tracheostomy Tube is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Covidien. The 510(k) number is K182861.

When was Shiley Neonatal/Pediatric Tracheostomy Tube approved by the FDA?

Shiley Neonatal/Pediatric Tracheostomy Tube received FDA 510(k) clearance on 2019-03-22, under approval number K182861.

What company makes Shiley Neonatal/Pediatric Tracheostomy Tube?

Shiley Neonatal/Pediatric Tracheostomy Tube is manufactured by Covidien.

What is the FDA product code for Shiley Neonatal/Pediatric Tracheostomy Tube?

The FDA product code for Shiley Neonatal/Pediatric Tracheostomy Tube is JOH.

Related Clinical Trials

NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING

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Related Devices (Code: JOH)

K151404ProTrach DualcareAtos Medical AB K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tubeSmiths Medical Asd, Inc. K180034Weinmann Tracheostomy Exchange SetCook Incorporated K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange SetCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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