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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K253359
Device Name Zenith Distal Access Long Sheath
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
QJP  
Subsequent Product Code
DQY  
Date Received09/30/2025
Decision Date 05/22/2026
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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