Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K021802 |
Device Name |
STEREOTAXIS CATHETER ADVANCER SYSTEM |
Applicant |
STEREOTAXIS, INC. |
4041 FOREST PARK AVE. |
ST. LOUIS,
MO
63108
|
|
Applicant Contact |
GARY M RAUVOLA |
Correspondent |
STEREOTAXIS, INC. |
4041 FOREST PARK AVE. |
ST. LOUIS,
MO
63108
|
|
Correspondent Contact |
GARY M RAUVOLA |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/03/2002 |
Decision Date | 04/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|