Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K905715 |
Device Name |
ACS ANGIOSCOPIC CATHETER |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Applicant Contact |
JANE E BEGGS |
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Correspondent Contact |
JANE E BEGGS |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 12/21/1990 |
Decision Date | 03/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|