# K040657: Boussignac/Vygon Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80

- Pathway: 510(k) (Traditional)
- Applicant: Vygon SA
- Decided: Jun 10, 2004 after 90 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802505 (1981). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802505: Double Lumen Tracheal Tube, National Catheter Co. Div. Mallinckrodt (1981) Summary page 1.
- K960795: Vygon Double Lumen Endotracheal Tube, Vygon Corp. (1996) Summary page 1.

## Most influential descendants
- K211543: Wei Nasal Jet Tube (2022), 0 descendants of its own

## Indications for use
The Boussignac/Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, the Boussignac/Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/Vygon Endotracheal Tube is intended for oral/nasal intubation. The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.

Source page: https://510kreport.com/device/K040657
Methodology: https://510kreport.com/methodology