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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K260394
Device Name Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
Applicant
Hangzhou Jimushi Meditech Co., Ltd.
Bldg. 1, # 12 Longtan Rd., Cangqian St.
Yuhang District
Hangzhou,  CN
Applicant Contact Fenlong Wu
Correspondent
Vee Care Asia Limited
9f-25, # 188, Sec. 4, Chenggong Rd., Neihu Dist.
Taipei,  TW 114049
Correspondent Contact Wei-Shan Hsu
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/06/2026
Decision Date 06/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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