510(k) K031553

SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES by Arcadia Medical Corporation — Product Code BTO

K031553 is an FDA 510(k) premarket notification submitted by Arcadia Medical Corporation for the device "SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES". The FDA issued a decision of Substantially Equivalent on November 18, 2003. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Arcadia Medical Corporation has at least 1 other 510(k) clearance on record.