510(k) K080339

MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) by Medsource International, LLC — Product Code BTR

K080339 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)". The FDA issued a decision of Substantially Equivalent on October 27, 2008. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Medsource International, LLC has at least 9 other 510(k) clearances on record.