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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 K242507
Device Name OBSIDIO™ Conformable Embolic
Applicant
Boston Scientific
1 Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact Heidi Shearer
Correspondent
Boston Scientific
1 Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact Heidi Shearer
Regulation Number870.3300
Classification Product Code
KRD  
Date Received08/22/2024
Decision Date 10/03/2024
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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