Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K141530 |
Device Name |
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS |
Applicant |
STEREOTAXIS, INC. |
2995 STEVEN MARTIN DR, |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
DIANA HORWITZ, PH.D., RAC |
Correspondent |
STEREOTAXIS, INC. |
2995 STEVEN MARTIN DR, |
FAIRFAX,
VA
22031
|
|
Correspondent Contact |
DIANA HORWITZ, PH.D., RAC |
Regulation Number | 870.1290
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2014 |
Decision Date | 12/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01656772
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|