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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
Applicant
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Applicant Contact GARY M RAUVOLA
Correspondent
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Correspondent 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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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