510(k) K202446

BD Preset Syringe & BD A-Line Syringe by Becton, Dickinson And Company — Product Code JKA

K202446 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Preset Syringe & BD A-Line Syringe". The FDA issued a decision of Substantially Equivalent on Sep 25, 2020. 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
Sep 25, 2020
Date Received
Aug 26, 2020
Clearance Type
Special
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)