Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K000235 |
Device Name |
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER |
Applicant |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Applicant Contact |
LESLIE WOOD |
Correspondent |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
9450 SOUTH STATE ST. |
SANDY,
UT
84070
|
|
Correspondent Contact |
LESLIE WOOD |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/27/2000 |
Decision Date | 04/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|