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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K163004
Device Name Radifocus Glidewire Advantage Track
Applicant
Ashitaka Factory of Terumo Coporation
150 Maimaigi-Cho
Fujinomiya Shizuoka,  JP 418-0015
Applicant Contact Dina Justice
Correspondent
Terumo Medical Corporation
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact Liang Lu
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/28/2016
Decision Date 01/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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