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510(k) K091591

Device
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
Applicant
FLEXICARE MEDICAL LTD.
510(k) number
K091591
Product code
BTR  
Decision
Substantially Equivalent (SESE)
Decision date
2009-06-17
Date received
2009-06-02
Regulation
868.5730
Classification name
Tube, Tracheal (w/wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
DAVID MOYNHAM
Address
Cynon Valley Business Park Moutain Ash Mid Glamorgan GB CF45 4ER CF45 4ER

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLC2025-10-06
K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLC2025-09-25
K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC2025-08-13
K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps2025-06-11
K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)Flexicare Medical Limited.2025-05-20
K242495LMA Fastrach ETT SUTeleflex Medical2025-04-29
K241451Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)Teleflex Incorporated2025-02-11
K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)Covidien, LLC2024-05-20
K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)Covidien2023-08-30
K211543Wei Nasal Jet TubeWell Lead Medical Co., Ltd.2022-07-21
K213028Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.2021-10-21
K200761Tenax Laser Resistant Endotracheal TubeBryan Medical, Inc.2020-11-25
K192120Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mmVenner Medical (Singapore) Pte, Ltd.2020-02-14
K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuffSalter Labs, Inc.2020-01-10
K182739Endotracheal Tube with Evacuation LumenWell Lead Medical Co., Ltd.2019-12-11

Legacy Summary#

summary

FDA Review#

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