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FDA 510(k)

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

K-Number: K193077 · 2020-06-01

ApplicantCovidien
Decision Date2020-06-01
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2020-06-01 under approval number K193077. 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 Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by Covidien. The 510(k) number is K193077.

When was Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff approved by the FDA?

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff received FDA 510(k) clearance on 2020-06-01, under approval number K193077.

What company makes Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is manufactured by Covidien.

What is the FDA product code for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

The FDA product code for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is JOH.

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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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