Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K870817 |
Device Name |
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
JOSEPH KICEINA |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
JOSEPH KICEINA |
Regulation Number | 880.5965 |
Classification Product Code |
|
Date Received | 03/03/1987 |
Decision Date | 07/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|