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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K123813
Device Name VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
Applicant
Vasonova, Inc.
155 Jefferson Dr., Suite 100
Menlo Park,  CA  94025
Applicant Contact CHRISTINE FORD
Correspondent
Vasonova, Inc.
155 Jefferson Dr., Suite 100
Menlo Park,  CA  94025
Correspondent Contact CHRISTINE FORD
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received12/11/2012
Decision Date 01/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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