Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K961583 |
Device Name |
A PORT DETACHED CATHETER SYSTEM CATALOG #1002 |
Applicant |
ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Applicant Contact |
BRADLEY J ENEGREN |
Correspondent |
ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Correspondent Contact |
BRADLEY J ENEGREN |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 04/24/1996 |
Decision Date | 07/18/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|