510(k) K220212

BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder by Becton, Dickinson And Company — Product Code JKA

K220212 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder". The FDA issued a decision of Substantially Equivalent on Mar 24, 2023. 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 329 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 2023
Date Received
Jan 26, 2022
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
510(k)