Device Classification Name |
clamp, vascular
|
510(k) Number |
K032125 |
Device Name |
CSTAT, MODELS 09-0014-01 AND 09-0014-02 |
Applicant |
VASCULAR CONTROL SYSTEMS, INC |
32236 PASEO ADELANTO, STE. E |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Applicant Contact |
KATHLEEN ROBERTS |
Correspondent |
VASCULAR CONTROL SYSTEMS, INC |
32236 PASEO ADELANTO, STE. E |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Correspondent Contact |
KATHLEEN ROBERTS |
Regulation Number | 870.4450
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/10/2003 |
Decision Date | 02/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|