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    K Number
    K964488
    Device Name
    DETACHABLE SILICONE BALLOON (DSB)
    Manufacturer
    TARGET THERAPEUTICS
    Date Cleared
    1998-04-21

    (529 days)

    Product Code
    MZQ, HBZ
    Regulation Number
    882.5950
    Why did this record match?
    Product Code :

    MZQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.
    Device Description
    The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.
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    K Number
    K965071
    Device Name
    DETACHABLE SLICONE BALLOON (DSB)
    Manufacturer
    TARGET THERAPEUTICS
    Date Cleared
    1998-04-21

    (488 days)

    Product Code
    MZQ, HBZ
    Regulation Number
    882.5950
    Why did this record match?
    Product Code :

    MZQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.
    Device Description
    The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.
    Ask a Question

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