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FDA 510(k)

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA

K-Number: K051416 · 2005-06-16

ApplicantMallinckrodt Medical
Decision Date2005-06-16
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 2005-06-16 under 510(k) number K051416. 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 TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA?

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Mallinckrodt Medical. The 510(k) number is K051416.

When did SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA receive FDA 510(k) clearance?

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA received FDA 510(k) clearance on 2005-06-16, under 510(k) number K051416.

Who is the listed applicant for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA?

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

What is the FDA product code for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA?

The FDA product code for SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA is JOH.

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Other records listing Mallinckrodt Medical as applicant

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K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

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Related Devices (Code: JOH)

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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, LLCK210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaSmiths Medical Asd, Inc.K203362TRACOE varioTracoe Medical GmbHK193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidienK193133Blue 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 IncorporatedK182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien

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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