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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K170223
Device Name Progreat
Applicant
Ashitaka Factory of Terumo Corporation
150 Maimaigi-Cho
Fujinomiya,  JP 418-0015
Applicant Contact LAUREN P. NITAHARA
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact LAUREN P. NITAHARA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/25/2017
Decision Date 07/21/2017
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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