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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 K253376
Device Name OBSIDIO™ Conformable Embolic (M0013972101010)
Applicant
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Liz Johnston
Correspondent
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Liz Johnston
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/30/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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