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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K252707
Device Name Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
Applicant
Suzhou Zenith Vascular SciTech Limited
Unit 101, 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
Unit 101, Bldg. 6, Block B, Phase 5, Biobay
#21 Dongyanli Rd., Sip Suzhou
Suzhou,  CN 215123
Correspondent Contact Yexia Zhang
Regulation Number870.1250
Classification Product Code
NRY  
Date Received08/27/2025
Decision Date 05/20/2026
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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