Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K842195 |
Device Name |
ADVANCED CARDIOVASCULAR-CORONARY GUID |
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 | 06/04/1984 |
Decision Date | 07/13/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|