Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K864349 |
Device Name |
MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS 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 | 11/04/1986 |
Decision Date | 02/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|