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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
510(k) Number K180102
Device Name Embozene Color-Advanced Microspheres
Applicant
Boston Scientific
3 Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Heidi Shearer
Correspondent
Boston Scientific
3 Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Heidi Shearer
Regulation Number876.5550
Classification Product Code
NOY  
Subsequent Product Codes
KRD   NAJ  
Date Received01/16/2018
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT02206243
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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