Atlas FDA

SHILEY FLEXTRA TRACHEOSTOMY TUBE

FDA 510(k) clearance K030787 · decided 2003-11-14

Clearance details

K-number
K030787
Device name
SHILEY FLEXTRA TRACHEOSTOMY TUBE
Applicant
Nellcor Puritan Bennett, Inc.
Decision
Substantially Equivalent
Date received
2003-03-12
Decision date
2003-11-14
Days to decision
247 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Pleasanton, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Shiley™ 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 XLT (K251313)Covidien, LLC2025-12-29
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TRACOE vario (K203362)Tracoe Medical GmbH2021-08-05
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (K193077)Covidien2020-06-01
Blue 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 Set (K193133)Cook Incorporated2019-12-12
Shiley Neonatal/Pediatric Tracheostomy Tube (K182861)Covidien2019-03-22
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 Tracheostomy Kit with BLUselect Suctionaid tube (K173912)Smiths Medical Asd, Inc.2018-05-08
Weinmann Tracheostomy Exchange Set (K180034)Cook Incorporated2018-05-07
TRACOE silcosoft Tracheostomy Tube (K172720)Tracoe Medical GmbH2018-04-27
Portex Blue Line Ultra Paediatric Tracheosomy Tube (K170720)Smiths Medical Asd, Inc.2017-12-07
ProTrach Dualcare (K151404)Atos Medical AB2016-02-12
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula (K150844)Covidien2015-07-14

Recalls involving this device

RecordFirmDate
Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, Flex recall (Z-0721-05)Nellcor Puritan Bennett2005-04-22

PMA approvals by this applicant

RecordFirmDate
NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR (P880013/S009)Nellcor Puritan Bennett, Inc.2002-12-17
HFV INFANT STAR VENTILATOR (P880013/S008)Nellcor Puritan Bennett, Inc.1998-04-07
HIGH FREQUENCY VENTILATOR (P880013/S007)Nellcor Puritan Bennett, Inc.1997-06-24
HFV STAR (P880013/S003)Nellcor Puritan Bennett, Inc.1993-10-26
HFV STAR (NEW MANUFACTURING SITE) (P880013/S002)Nellcor Puritan Bennett, Inc.1993-08-11
HFV STAR (P880013/S001)Nellcor Puritan Bennett, Inc.1993-02-05
INFANT STAR HIGH FREQUENCY VENTILATOR (P880013)Nellcor Puritan Bennett, Inc.1990-01-19