Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K822862 |
Device Name |
BRACHIAL CORONARY GUIDING CATHETER |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/27/1982 |
Decision Date | 10/18/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|