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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Control, Steerable
510(k) Number K150312
Device Name Vdrive system, Vdrive Duo, Vdrive with V-Sono
Applicant
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Applicant Contact JOHN NADELIN
Correspondent
Safis Solutions, LLC
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact DIANE HORWITZ
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DQX  
Date Received02/09/2015
Decision Date 06/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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