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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 K252317
Device Name Zenith Micro Guidewire
Applicant
Suzhou Zenith Vascular SciTech Limited
Bldg. 6, Block B, Phase 5, Biobay
#21 Dongyanli Rd., Sip Suzhou
Suzhou,  CN 215123
Applicant Contact Yexia Zhang
Correspondent
Suzhou Zenith Vascular SciTech Limited
Bldg. 6, Block B, Phase 5, Biobay
#21 Dongyanli Rd., Sip Suzhou
Suzhou,  CN 215123
Correspondent Contact Yexia Zhang
Regulation Number870.1330
Classification Product Code
MOF  
Subsequent Product Code
DQX  
Date Received07/25/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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