510(k) K102520

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

K102520 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 January 6, 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 Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2011
Date Received
September 2, 2010
Clearance Type
Special
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