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Boussignac/VYGON Endotracheal Tube, Model 6501.25/30/35 and 6502.70/75/80

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040657

by Vygon SA

Identifiers

510(k) Number
K040657 FDA 510(k)
FDA Product Code
BTR FDA 510(k)
Models / Variants
6501.25 FDA 510(k)
30 FDA 510(k)
35 FDA 510(k)
6502.70 FDA 510(k)
75 FDA 510(k)
80 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 Boussignac/VYGON Endotracheal Tube is a tracheal tube with canaliculi in the tube wall. The injection of gas through these canaliculi causes turbulence at the distal end of the tube, generating a 'virtual valve'. This device is designed for use in continuous positive airway pressure ventilation during resuscitation procedures.

The device is supplied in various sizes (6501.25/30/35 and 6502.70/75/80) and is intended for single-use in anesthesiology settings. It is regulated under FDA 510(k) clearance with product code BTR and regulation number 868.5730. The device is classified as a Class II medical device for tracheal tubes with or without connectors.

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: PDF BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL… - FDA.report, CPR Boussignac system - Respiratory products | Vygon, Bougie Boussignac - Invasive ventilation | Vygon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vygon SA

Sources (1)

  • FDA 510(k) K040657 24 fields · synced Oct 6, 2026