STEREOTAXIS CATHETER ADVANCER SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K021802
Device Name STEREOTAXIS CATHETER ADVANCER SYSTEM
Original Applicant
STEREOTAXIS, INC.
4041 forest park ave.
st. louis, 
MO 
63108

Original Contact gary m rauvola
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQX  
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