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510(k) Data Aggregation

    K Number
    K021210
    Device Name
    ARTERIA OCCLUSION BALLOON
    Manufacturer
    ARTERIA MEDICAL SCIENCE, INC.
    Date Cleared
    2002-10-28

    (194 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIA MEDICAL SCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
    Device Description
    The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
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    K Number
    K021293
    Device Name
    ARTERIA BLOOD FILTER
    Manufacturer
    ARTERIA MEDICAL SCIENCE, INC.
    Date Cleared
    2002-08-22

    (121 days)

    Product Code
    FPB
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIA MEDICAL SCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.
    Device Description
    The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.
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    K Number
    K001917
    Device Name
    PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
    Manufacturer
    ARTERIA MEDICAL SCIENCE, INC.
    Date Cleared
    2001-06-06

    (348 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTERIA MEDICAL SCIENCE, INC.

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