510(k) K060094

ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES by Arcadia Medical Corporation — Product Code BTR

K060094 is an FDA 510(k) premarket notification submitted by Arcadia Medical Corporation for the device "ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on May 8, 2006. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Arcadia Medical Corporation has at least 1 other 510(k) clearance on record.