Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K102520 |
Device Name |
BD NEXIVA CLOSED IV CATHETER SYSTEM |
Applicant |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Applicant Contact |
JUSTICE ALDER |
Correspondent |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Correspondent Contact |
JUSTICE ALDER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/02/2010 |
Decision Date | 01/06/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|