510(k) K111366

BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM by Becton, Dickinson and Company (BD) — Product Code FOZ

K111366 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company (BD) for the device "BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 2011. 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 and Company (BD) has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
May 16, 2011
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