510(k) K945458

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GIM

K945458 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 6, 1995. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.