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)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan:
1) Uncuffed 6.0 mm, Product Code 5-10412
2) Uncuffed 6.5 mm, Product Code 5-10413
3) Uncuffed 7.0 mm, Product Code 5-10414
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan:
1) Preformed 6.0 mm, Product Codes:
a) 5-22212,
b) 5-22312,
c) 5-22112,
d) 5-22012,
2) Preformed 6.5 mm, Product Codes:
a) 5-22313,
b) 5-22213,
c) 5-22013,
d) 5-22113, Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan:
1) EZ-ENDO 6.0 mm, Product Code 5-22512
2) EZ-ENDO 6.5 mm, Product Code 5-22513
3) EZ-ENDO 7.0 mm, Product Code 5-22514
4) EZ-ENDO 7.5 mm, Product Code 5-22515
5) EZ-ENDO 8.0 mm, Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan:
1) CF 6.0 mm, Product Codes: 5-10112, 5-10212
2) CF 6.5 mm, Product Codes: 5-10113, 5-10213
3) CF 7.0 mm, Product Codes: 5-10114, 5-10214
4) CF 7.5 mm, Product Codes: V5-10115 Terminated |
BTR | K822082 |
| Jun 19, 2019 | Teleflex Medical Hudson RCI Sheridan LTS, Product Code 5-11112
Product Usage:
Tracheal tube/airway management Terminated |
BTR | K822082 |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0 Terminated |
BTR | K935842 |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0 Terminated |
BTR | K935842 |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0 Terminated |
BTR | K935842 |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0 Terminated |
BTR | K935842 |
| Apr 1, 2019 | Teleflex Medical RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 Terminated |
BTR | K935842 |
| Feb 9, 2017 | Teleflex Medical Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315
A tracheal tube is inserted into a patients mouth or nose for airway management Terminated |
BTR | K822082 |
| Nov 9, 2016 | Teleflex Medical LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal Terminated |
BTR | K021044 |
| Jul 19, 2016 | Parker Medical Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box.
Product Usage:
The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating pat Terminated |
BTR | K110269 |
| Jun 9, 2016 | Teleflex Medical Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated.
A tracheal tube is inserted into a patients mouth or nose for airwa Terminated |
BTR | K822082 |
| Apr 4, 2016 | Stryker Sustainability Solutions Launcher Guiding Catheter
Model #LA6EBU30. Used in the coronary or peripheral vascular system.. Terminated |
BTR | K082520 |
| Apr 4, 2016 | Stryker Sustainability Solutions Mallinckrodt Evac Tracheal Tubes
Model #124170-MALLINCKRODT & 124175 Terminated |
BTR | K082520 |
| Feb 17, 2015 | Teleflex, Inc. RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the p Terminated |
BTR | K990619 |
| Feb 10, 2015 | Teleflex Medical Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical. Terminated |
BTR | K822082 |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | K131254 |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | K131254 |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | K131254 |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC.
Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | K131254 |
| Dec 24, 2014 | Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se Terminated |
BTR | K131254 |
| Dec 12, 2014 | Teleflex Medical Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708.
Designed for oral and nasal intubation and are indicated for airway management. Terminated |
BTR | K822082 |
| Aug 28, 2014 | Smiths Medical ASD, Inc. H4052 Endo Tube Holder, Pedi 3.0mm
Pediatric Endotracheal Intubation Kit Terminated |
BTR | None listed |
| Aug 28, 2014 | Smiths Medical ASD, Inc. H4051 Endo Tube Holder, Pedi 2.5mm
Pediatric Endotracheal Intubation Kit Terminated |
BTR | None listed |
| Aug 28, 2014 | Smiths Medical ASD, Inc. H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder
Pediatric Endotracheal Intubation Kit Terminated |
BTR | K790312 |
| Aug 28, 2014 | Smiths Medical ASD, Inc. H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn
Pediatric Endotracheal Intubation Kit Terminated |
BTR | K790312 |
| Aug 28, 2014 | Smiths Medical ASD, Inc. H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder
Pediatric Endotracheal Intubation Kit Terminated |
BTR | K790312 |
| Aug 28, 2014 | Smiths Medical ASD, Inc. 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn
Pediatric Endotracheal Intubation Kit Terminated |
BTR | K790312 |
| Jun 23, 2014 | Teleflex Medical RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH.
A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and use Terminated |
BTR | K935842 |
| Jun 11, 2014 | Smiths Medical ASD, Inc. Portex Low Dead Space Connector with Sideport, 3.5mm
Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mec Terminated |
BTR | K790312 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or m Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to mai Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint Terminated |
BTR | K091761 |
| Feb 21, 2014 | Teleflex Medical ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only,
Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main Terminated |
BTR | K091761 |
| Jul 17, 2012 | LMA North America Inc LMA Esophageal Intubation Detector (EID), Catalog Number EID100
The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device i Terminated |
BTR | K930741 |
| Nov 12, 2009 | Centurion Medical Products Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115. Terminated |
BTR | None listed |
| Nov 12, 2009 | Centurion Medical Products Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110.
Aspiration tray containing Portex uncuffed pedi Terminated |
BTR | None listed |
| Sep 18, 2009 | Smiths Medical Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm
Product Code: 100/134/035.
Intended for oral and/or nasal intubation for airway management. Terminated |
BTR | None listed |
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