Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K012050 |
Device Name |
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Applicant Contact |
SABA MODJARRAD |
Correspondent |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054 -2807
|
|
Correspondent Contact |
SABA MODJARRAD |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/02/2001 |
Decision Date | 09/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|