POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS


Device Classification Name

wire, guide, catheter

510(k) Number K080637
Device Name POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
Applicant
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis, 
MO 
63108

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

Correspodent Contact dennis pozzo
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 03/06/2008
Decision Date 08/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No