510(k) K980098

VACUTAINER BRAND PRONTO NEEDLES HOLDER by Becton Dickinson Vacutainer Systems — Product Code JKA

K980098 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "VACUTAINER BRAND PRONTO NEEDLES HOLDER". The FDA issued a decision of Substantially Equivalent on February 5, 1998. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.