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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQX  
Date Received06/03/2002
Decision Date 04/08/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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