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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 K141530
Device Name VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
Applicant
Stereotaxis, Inc.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Applicant Contact DIANA HORWITZ, PH.D., RAC
Correspondent
Stereotaxis, Inc.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact DIANA HORWITZ, PH.D., RAC
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DQX  
Date Received06/09/2014
Decision Date 12/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01656772
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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