Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K972484 |
Device Name |
ACS VIKING GUIDING CATHETER |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Applicant Contact |
Sara Toyloy |
Correspondent |
GUIDANT CORP. |
3200 LAKESIDE DR. |
P.O. BOX 58167 |
SANTA CLARA,
CA
95052 -8167
|
|
Correspondent Contact |
Sara Toyloy |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/02/1997 |
Decision Date | 09/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|