ClearanceBrief
Panels › Anesthesiology › Product code BTR · Class 2

Tube, Tracheal (W/Wo Connector)

Regulation 868.5730

2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
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Top companies in BTR

DateFirm and productCodeLinked 510(k)
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
Open, Classified
BTRK961837
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
Open, Classified
BTRK780900
Jun 29, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
Open, Classified
BTRK780900
Apr 1, 2023Covidien
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trac
Open, Classified
BTRK871204
Jan 23, 2023TELEFLEX LLC
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c
Open, Classified
BTRNone listed
Jan 23, 2023TELEFLEX LLC
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSC
Open, Classified
BTRK961837
Jan 23, 2023TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Open, Classified
BTRK780900
Aug 9, 2021Smiths Medical ASD Inc.
Bivona Uncuffed Wire Endotracheal Tubes,
Terminated
BTRK792035
Aug 9, 2021Smiths Medical ASD Inc.
Bivona Aire-Cuf Endotracheal Tube
Terminated
BTRK792035
Jul 16, 2021Teleflex Medical Europe Ltd
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085
Terminated
BTRK961837
Jul 16, 2021Teleflex Medical Europe Ltd
RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i)
Terminated
BTRK961837
Jul 16, 2021Teleflex Medical Europe Ltd
RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Terminated
BTRK961837
Jul 16, 2021Teleflex Medical Europe Ltd
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Terminated
BTRK780900
Nov 26, 2020Flexicare Medical Ltd.
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Terminated
BTRK091591
May 29, 2020TELEFLEX MEDICAL INC
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Co
Terminated
BTRK935842
Sep 9, 2019Teleflex Medical
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm,
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-1011
Terminated
BTRK822082
Sep 9, 2019Teleflex Medical
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Jul 30, 2019Centurion Medical Products Corporation
Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
Terminated
BTRK091761
K822082
Jun 19, 2019Teleflex Medical
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tr
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316
Terminated
BTRK822082

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