Device Classification Name |
introducer, catheter
|
510(k) Number |
K934624 |
Device Name |
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE |
Applicant |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Applicant Contact |
JUDITH P PALIN |
Correspondent |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Correspondent Contact |
JUDITH P PALIN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/27/1993 |
Decision Date | 04/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|