510(k) K083031

PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT by Smiths Medical Asd, Inc. — Product Code BTO

K083031 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT". The FDA issued a decision of Substantially Equivalent on August 18, 2009. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.