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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 K140804
Device Name VDRIVE WITH V-LOOP/ VDRIVE DUO
Applicant
Stereotaxis, Inc.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Applicant Contact DIANE HORWITZ, PH.D., RAC
Correspondent
Stereotaxis, Inc.
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact DIANE HORWITZ, PH.D., RAC
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DQX  
Date Received03/31/2014
Decision Date 09/03/2014
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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