510(k) K090450

MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT by Gish Biomedical, Inc. — Product Code DTZ

K090450 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT". The FDA issued a decision of Substantially Equivalent on September 18, 2009. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Gish Biomedical, Inc. has at least 10 other 510(k) clearances on record.