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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K243534
Device Name Micro Catheter
Applicant
Suzhou Zenith Vascular SciTech Limited
C13-101, Biobay, #218 Xinghu St., Sip
Suzhou,  CN 215123
Applicant Contact Xia Jie
Correspondent
Suzhou Zenith Vascular SciTech Limited
C13-101, Biobay, #218 Xinghu St., Sip
Suzhou,  CN 215123
Correspondent Contact Xia Jie
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Code
QJP  
Date Received11/15/2024
Decision Date 07/30/2025
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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