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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 K240859
Device Name Glidewire GT-R
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku
Tokyo,  JP 151-0072
Applicant Contact Qing Liu
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Qing Liu
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/28/2024
Decision Date 08/21/2024
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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