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510(k) K173912

Device
BLUperc 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 T
Applicant
Smiths Medical ASD, Inc.
510(k) number
K173912
Product code
JOH  
Decision
Substantially Equivalent (SESE)
Decision date
2018-05-08
Date received
2017-12-22
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
Donna M. Semlak
Address
6000 Nathan Ln. N Plymouth MN US 55442 55442

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
K182861Shiley Neonatal/Pediatric Tracheostomy TubeCovidien2019-03-22
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

Legacy Summary#

summary

FDA Review#

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