Etview Tracheoscopic Ventilation Tube (TVT)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121028 FDA 510(k)
- FDA Product Code
- BTR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5730 FDA 510(k)
- Regulation Number
- 868.5730 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Etview Tracheoscopic Ventilation Tube (TVT) is a tracheal tube intended for intubation procedures. It is designed to serve as a temporary artificial airway in adults requiring mechanical ventilation, suitable for both oral and nasal intubations. The TVT incorporates a video camera and light source at its tip, providing continuous visualization of the airway during non-difficult and difficult intubation procedures.
The TVT is a single-use device that allows for continuous monitoring of tube position during mechanical ventilation to help prevent displacement complications. It is supplied as a sterile device and is intended for one-time use only. The device is classified under product code BTR and has received FDA 510(k) clearance with the K121028 number, indicating it is substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRACHEOSCOPIC VENTILATION TUBE (TVT) (K082420) — FDA 510 (k ..., ETView tracheoscopic ventilation tube for surveillance after tube ..., The use of ETView endotracheal tube for surveillance after tube ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121028 | Class II | Active |
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Manufacturer
- Manufacturer
- Etview , Ltd.
Sources (1)
- FDA 510(k) K121028 24 fields · synced Sep 28, 2026