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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 K103255
Device Name VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
Applicant
Vasonova, Inc.
155 Jefferson Dr., Suite 100
Menlo Park,  CA  94025
Applicant Contact KIM TOMPKINS, RN, MBA
Correspondent
Vasonova, Inc.
155 Jefferson Dr., Suite 100
Menlo Park,  CA  94025
Correspondent Contact KIM TOMPKINS, RN, MBA
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received11/03/2010
Decision Date 02/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01232933
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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