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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Midline Catheter
510(k) Number K252402
Device Name Midline Catheter
Applicant
Terumo Medical Products (Hangzhou) Co., Ltd.
M4-9-5, Hangzhou Economic & Technological Development Zone
Hangzhou,  CN 310018
Applicant Contact Kimberly Jacob-Paredes
Correspondent
Terumo Medical Products (Hangzhou) Co., Ltd.
M4-9-5, Hangzhou Economic & Technological Development Zone
Hangzhou,  CN 310018
Correspondent Contact Kimberly Jacob-Paredes
Regulation Number880.5200
Classification Product Code
PND  
Subsequent Product Code
FOZ  
Date Received07/31/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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