FDA.reportPublic FDA data

510(k) K182861

Device
Shiley Neonatal/Pediatric Tracheostomy Tube
Applicant
Covidien
510(k) number
K182861
Product code
JOH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-22
Date received
2018-10-11
Regulation
868.5800
Classification name
Tube Tracheostomy And Tube Cuff
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yaara Basevitch
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLTCovidien, LLC2025-12-29
K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.2021-11-26
K203362TRACOE varioTracoe Medical GmbH2021-08-05
K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien2020-06-01
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 Incorporated2019-12-12
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.2018-05-08
K180034Weinmann Tracheostomy Exchange SetCook Incorporated2018-05-07
K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH2018-04-27
K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc.2017-12-07
K151404ProTrach DualcareAtos Medical AB2016-02-12
K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner CannulaCovidien2015-07-14
K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner CannulaCovidien2015-02-24
K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien2015-02-13
K133528H&H EMERGENCY CRICOTHYROTOMY KITH & H Medical Corporation2014-07-03
K133173RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SETTeleflexmedical, Inc.2014-05-23