510(k) K915481

B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DWD

K915481 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT". The FDA issued a decision of Substantially Equivalent on January 7, 1992. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.