510(k) K971259

COMBIPORT FLUID LAVAGE DEVICE by B.Braun Medical, Inc. — Product Code KDH

K971259 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "COMBIPORT FLUID LAVAGE DEVICE". The FDA issued a decision of Substantially Equivalent on October 27, 1997. The device falls under product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration), a Class II device regulated under 21 CFR 876.5980. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.