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510(k) Data Aggregation

    K Number
    K032619
    Device Name
    MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
    Manufacturer
    SURGICA CORP.
    Date Cleared
    2004-02-13

    (171 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
    Device Description
    Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
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    K Number
    K020033
    Device Name
    MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
    Manufacturer
    SURGICA CORP.
    Date Cleared
    2002-05-31

    (147 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgica Corporation MaxiStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
    Device Description
    Surgica Corporation MaxiStat™ Polyvinyl Alcohol (PVA) foam embolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyvinyl Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
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    K Number
    K001678
    Device Name
    PVA FOAM EMBOLIZATION PARTICLES
    Manufacturer
    SURGICA CORP.
    Date Cleared
    2001-01-25

    (238 days)

    Product Code
    HCG
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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