Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K021363 |
Device Name |
ENDOVASCULAR GUIDE WIRE |
Applicant |
STEREOTAXIS, INC. |
4041 FOREST PARK AVE. |
ST. LOUIS,
MO
63108
|
|
Applicant Contact |
GARY RAUVOLA |
Correspondent |
STEREOTAXIS, INC. |
4041 FOREST PARK AVE. |
ST. LOUIS,
MO
63108
|
|
Correspondent Contact |
GARY RAUVOLA |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 04/30/2002 |
Decision Date | 11/27/2002 |
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
|
|
|