510(k) K243649

BD Vacutainer® Multiple Sample Luer Adapter by Becton, Dickinson and Company — Product Code JKA

K243649 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD Vacutainer® Multiple Sample Luer Adapter". The FDA issued a decision of Substantially Equivalent on March 21, 2025. 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 and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
November 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type