510(k) K060945

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT by Smiths Medical International — Product Code BTO

K060945 is an FDA 510(k) premarket notification submitted by Smiths Medical International for the device "PORTEX PERCUTANEOUS TRACHEOSTOMY KIT". The FDA issued a decision of Substantially Equivalent on June 19, 2006. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Smiths Medical International has at least 3 other 510(k) clearances on record.