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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K142122
FOIA Releasable 510(k) K142122
Device Name RADAR VASCULAR COMPRESSION DEVICE
Applicant
Advanced Vascular Dynamics
4252 SE International Way, Suite F
Milwaukie,  OR  97222
Applicant Contact MATTHEW SEMLER
Correspondent
Advanced Vascular Dynamics
4252 SE International Way, Suite F
Milwaukie,  OR  97222
Correspondent Contact MATTHEW SEMLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/04/2014
Decision Date 12/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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