Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K905269 |
Device Name |
OCHSNER 500 VASCULAR PROSTHESIS |
Applicant |
INTERVASCULAR, INC. |
16331 BAY VISTA DR. |
CLEARWATER,
FL
33760 -3130
|
|
Applicant Contact |
MICHAEL P DAYTON |
Correspondent |
INTERVASCULAR, INC. |
16331 BAY VISTA DR. |
CLEARWATER,
FL
33760 -3130
|
|
Correspondent Contact |
MICHAEL P DAYTON |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 11/23/1990 |
Decision Date | 04/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|