510(k) K023381

VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING by Gish Biomedical, Inc. — Product Code DTZ

K023381 is an FDA 510(k) premarket notification submitted by Gish Biomedical, Inc. for the device "VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING". The FDA issued a decision of Substantially Equivalent on March 31, 2003. 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.