510(k) K192493

BD Cathena (TM) Safety IV Catheter by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code FOZ

K192493 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD Cathena (TM) Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on January 24, 2020. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
September 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type