Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K953571 |
Device Name |
VASPORT VASCULAR ACCESS PORT |
Applicant |
GISH BIOMEDICAL, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614 -5821
|
|
Applicant Contact |
DEBRA J KRIDNER |
Correspondent |
GISH BIOMEDICAL, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614 -5821
|
|
Correspondent Contact |
DEBRA J KRIDNER |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 07/31/1995 |
Decision Date | 10/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|