Panels › Anesthesiology › Product code CBI · Class 2
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Regulation 868.5740
2510(k)s in 12 months (34 all time)
0recalls in 12 months (10 all time)
8recalls that name a 510(k)
Top companies in CBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Medical | 1 | 7 |
| Cook Incorporated | 5 | 0 |
| Etview , Ltd. | 4 | 0 |
| Pulmonx Corporation | 4 | 0 |
| Ambu Inc. | 0 | 2 |
| Daiken Medical Co, Ltd. | 2 | 0 |
| Shenzhen Insighters Medical Technology Co., Ltd. | 2 | 0 |
| Sheridan Catheter Corp. | 2 | 0 |
| Ambu A/S | 1 | 0 |
| Ez-Blocker B.V. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Ambu Inc. Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000) Open, Classified |
CBI | K203749 |
| Jun 3, 2022 | Ambu Inc. Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000,
412371000,
412391000,
412411000 Open, Classified |
CBI | K203749 |
| Oct 30, 2019 | Teleflex Medical HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronc Terminated |
CBI | K851856 |
| Mar 3, 2017 | Parker Medical Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1,
H-PFTDL-41-1.
Terminated |
CBI | K092886 K984528 |
| Aug 20, 2015 | Teleflex Medical HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile.
Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. Terminated |
CBI | None listed |
| Aug 20, 2015 | Teleflex Medical HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile.
Used to aspirate liquids or semisolids from a patient's upper airway. Terminated |
CBI | None listed |
| Aug 20, 2015 | Teleflex Medical HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
Intended for use in thoracic surgery, bronchospirometry, for Terminated |
CBI | K851856 |
| Aug 20, 2015 | Teleflex Medical HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile.
Intended for use in thoracic surgery, bronchospirometry, for t Terminated |
CBI | K961977 |
| Apr 6, 2005 | Teleflex Medical Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Ca Terminated |
CBI | K851856 |
| Apr 6, 2005 | Teleflex Medical Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589- Terminated |
CBI | K851856 |
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