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510(k) K242507

OBSIDIO™ Conformable Embolic by Boston Scientific — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2024
Date Received
August 22, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vascular, For Promoting Embolization
Device Class
Class II
Regulation Number
870.3300
Review Panel
CV
Submission Type

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