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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K250209
Device Name Polyvinyl Alcohol Embolic Microspheres
Applicant
Canyon Medical, Inc.
Bldg. 3, Phase 2 Accelerator, # 11 Yaogu Ave.
Jiangbei New Area
Nanjing,  CN 210032
Applicant Contact Huiqi Jiang
Correspondent
Canyon Medical, Inc.
Bldg. 3, Phase 2 Accelerator, # 11 Yaogu Ave.
Jiangbei New Area
Nanjing,  CN 210032
Correspondent Contact Huiqi Jiang
Regulation Number870.3300
Classification Product Code
KRD  
Date Received01/24/2025
Decision Date 09/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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