510(k) K040657

BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 by Vygon SA — Product Code BTR

K040657 is an FDA 510(k) premarket notification submitted by Vygon SA for the device "BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80". The FDA issued a decision of Substantially Equivalent on June 10, 2004. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Vygon SA has at least 10 other 510(k) clearances on record.