Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K872998 |
Device Name |
VITAACCESS (TM) CATHETER INTRODUCER SYSTEM |
Applicant |
VITAPHORE CORP. |
887 INDUSTRIAL RD. |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
SOPHIA PESOTCHINSKY |
Correspondent |
VITAPHORE CORP. |
887 INDUSTRIAL RD. |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
SOPHIA PESOTCHINSKY |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/03/1987 |
Decision Date | 03/24/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|