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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K252122
Device Name DCwire Micro-guidewire
Applicant
Shanghai Achieva Medical Suzhou Co., Ltd.
#8 Zhongtian Aly., Suzhou Industrial Park
#133 Fangzhong St., Suzhou Industrial Park
Suzhou,  CN 215028
Applicant Contact Christine Zeng
Correspondent
Shanghai Achieva Medical Suzhou Co., Ltd.
#8 Zhongtian Aly., Suzhou Industrial Park
#133 Fangzhong St., Suzhou Industrial Park
Suzhou,  CN 215028
Correspondent Contact Christine Zeng
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received07/07/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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