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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K161546
Device Name R2P SlenGuide
Applicant
Ashitaka Factory of Terumo Corporation
150 Maimaigi-Cho
Fujinomiya Shizuoka,  JP 418-0015
Applicant Contact PHEBE VARGHESE
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact PHEBE VARGHESE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/03/2016
Decision Date 10/14/2016
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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