FDA 510(k)

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

Numéro K : K193077 · 2020-06-01

Date de décision2020-06-01

Code produitJOH

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193077. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Covidien. The 510(k) number is K193077.

When did Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff receive FDA 510(k) clearance?

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

Who is the listed applicant for Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : JOH)

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, LLC K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe 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 K182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien 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.

Source officielle

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