Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K032632 |
Device Name |
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH |
Applicant |
ESTECH, INC. |
4135 BLACKHAWK PLAZA CIRCLE |
SUITE 150 |
DANVILLE,
CA
94506
|
|
Applicant Contact |
ARTHUR BERTOLERO |
Correspondent |
ESTECH, INC. |
4135 BLACKHAWK PLAZA CIRCLE |
SUITE 150 |
DANVILLE,
CA
94506
|
|
Correspondent Contact |
ARTHUR BERTOLERO |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/26/2003 |
Decision Date | 10/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|