VDRIVE W/V-SONO


Device Classification Name

wire, guide, catheter

510(k) Number K122659
Device Name VDRIVE W/V-SONO
Applicant
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis, 
MO 
63108

Applicant Contact horwitz
Correspondent
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis, 
MO 
63108

Correspodent Contact horwitz
Regulation Number 870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXX  
Date Received 08/31/2012
Decision Date 07/26/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No