Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K170283 |
Device Name |
BD Nexiva Diffusics Closed IV Catheter System |
Applicant |
Becton, Dickinson and Company |
9450 South State Street |
Sandy,
UT
84070
|
|
Applicant Contact |
Amy Honey |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/30/2017 |
Decision Date | 02/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|