Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K110443 |
Device Name |
BD INSYTE AUTOGUARD BC |
Applicant |
BECTON DICKINSON & CO. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Applicant Contact |
RAND PUGMIRE |
Correspondent |
BECTON DICKINSON & CO. |
9450 SOUTH STATE STREET |
SANDY,
UT
84070
|
|
Correspondent Contact |
RAND PUGMIRE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/16/2011 |
Decision Date | 07/19/2011 |
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
|
|
|