510(k) K252506

BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder by Becton, Dickinson and Company — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2026
Date Received
August 8, 2025
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