510(k) K183399

BD Nexiva Closed IV Catheter System by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code FOZ

K183399 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD Nexiva Closed IV Catheter System". The FDA issued a decision of Substantially Equivalent on March 20, 2019. 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
March 20, 2019
Date Received
December 7, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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