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510(k) Data Aggregation

    K Number
    K031583
    Device Name
    MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
    Manufacturer
    INTEGRATED VASCULAR SYSTEMS, INC.
    Date Cleared
    2003-06-16

    (26 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATED VASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
    Device Description
    The IVS Introducer Set consists of a 7 French Introducer Sheath and a Dilator with or without a 0.38" (0.97mm) 'J' tip Guidewire.
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    K Number
    K030723
    Device Name
    IVS INTRODUCER SET, MODEL 1003
    Manufacturer
    INTEGRATED VASCULAR SYSTEMS, INC.
    Date Cleared
    2003-04-03

    (27 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATED VASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
    Device Description
    The IVS Introducer Set consists of a 6 French Introducer Sheath, a Dilator and a 0.38" (0.97mm) 'J' tip Guidewire
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    K Number
    K020879
    Device Name
    IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001
    Manufacturer
    INTEGRATED VASCULAR SYSTEMS, INC.
    Date Cleared
    2002-09-25

    (191 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATED VASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.
    Device Description
    The IVS Clip Closure System consists of an extravascular implantable nitinol clip mounted on an Introducer Sheath. A clip applier acts to release the clip into vascular tissue where it closes vascular puncture wounds.
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