510(k) K123734

BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code FOZ

K123734 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 2013. 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 17, 2013
Date Received
December 5, 2012
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