Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K123734 |
Device Name |
BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM |
Applicant |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Applicant Contact |
KIMBERLY GEISLER |
Correspondent |
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Correspondent Contact |
KIMBERLY GEISLER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/05/2012 |
Decision Date | 01/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|