510(k) K925615

SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE by Sorin Biomedica, Fiat, USA, Inc. — Product Code CBI

K925615 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE". The FDA issued a decision of Substantially Equivalent on March 26, 1993. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.