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510(k) Data Aggregation

    K Number
    K253376
    Device Name
    OBSIDIO™ Conformable Embolic (M0013972101010)
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2025-10-30

    (30 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K242507
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:

    • Hypervascular tumors
    • Blood vessels to occlude blood flow for controlling bleeding/hemostasis in the peripheral vasculature
    Device Description

    The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.

    AI/ML Overview

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