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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 K250751
Device Name DualView Catheter
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku
Tokyo,  JP 151-0072
Applicant Contact Patrick McDonald
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Patrick McDonald
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
OBJ  
Date Received03/12/2025
Decision Date 07/17/2025
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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