FDA.reportPublic FDA data

510(k) K223130

Device
Shiley? Pediatric Oral/Nasal Endotracheal Tube with TaperGuard? Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
Applicant
Covidien
510(k) number
K223130
Product code
BTR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-30
Date received
2022-10-03
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
No

Applicant Contact#

Contact
Anila Tarte
Address
6135 Gunbarrel Ave. Boulder CO US 80301 80301

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
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
K192324Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc.2019-12-06