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510(k) K253376

OBSIDIO™ Conformable Embolic (M0013972101010) by Boston Scientific Corporation — Product Code KRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
September 30, 2025
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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Other clearances for product code KRD

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  • K242608 — Embozene Color-Advanced Microspheres (January 17, 2025)
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