ENDOVASCULAR GUIDE WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K021363
Device Name ENDOVASCULAR GUIDE WIRE
Original Applicant
STEREOTAXIS, INC.
4041 forest park ave.
st. louis, 
MO 
63108

Original Contact gary rauvola
Regulation Number 870.1330
Classification Product Code
DQX  
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