| Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
| 510(k) Number |
K863750 |
| Device Name |
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER |
| Applicant |
| C.R. Bard, Inc. |
| 111 Spring St. |
|
Murray Hill,
NJ
07974
|
|
| Applicant Contact |
CATHERINE V BEATH |
| Correspondent |
| C.R. Bard, Inc. |
| 111 Spring St. |
|
Murray Hill,
NJ
07974
|
|
| Correspondent Contact |
CATHERINE V BEATH |
| Regulation Number | 880.5965 |
| Classification Product Code |
|
| Date Received | 09/25/1986 |
| Decision Date | 12/01/1986 |
| 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
|
|
|