FDA 510(k)

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

K-Number: K962173 · 1996-10-04

Decision Date1996-10-04

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1996-10-04 under 510(k) number K962173. 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 SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES?

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1996-10-04. The listed applicant is Mallinckrodt Medical. The 510(k) number is K962173.

When did SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES receive FDA 510(k) clearance?

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES received FDA 510(k) clearance on 1996-10-04, under 510(k) number K962173.

Who is the listed applicant for SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES?

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 SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES?

The FDA product code for SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES is JOH.

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Other records listing Mallinckrodt Medical as applicant

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA K972258HI-CARE CLOSED SUCTION SYSTEM K971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF K963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

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Related Devices (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 K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien 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

Official Source

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