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510(k) Data Aggregation

    K Number
    K253677

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-15

    (24 days)

    Product Code
    Regulation Number
    870.3300
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tembo Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.

    Device Description

    The Tembo Embolic System consists of biocompatible, dry resorbable particles of porcine gelatin in a 10 mL syringe with a non-vented luer lock cap.

    The Tembo Embolic System is a gelatin agent and a sterile, single use, medical device intended for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. The Tembo Embolic System particles are hydrated using commercially available contrast media or contrast mixed with saline. Once hydrated, the material is injected into the target blood vessels via a commercially available microcatheter for occlusion of target vasculature. The dry Tembo Embolic System gelatin particles are between 85 µm and 255 µm and the hydrated gelatin particles are between 150 µm and 450 µm.

    AI/ML Overview

    N/A

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