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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wire, Guide, Catheter
510(k) Number K021363
Device Name ENDOVASCULAR GUIDE WIRE
Applicant
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Applicant Contact GARY RAUVOLA
Correspondent
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Correspondent Contact GARY RAUVOLA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/30/2002
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
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