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510(k) Data Aggregation

    K Number
    K073400
    Device Name
    VARICATH PERIPHERAL INFUSION CATHETER
    Manufacturer
    VEINRX INC.
    Date Cleared
    2007-12-20

    (16 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEINRX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VariCath Peripheral Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
    Device Description
    The VeinRx VariCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a variable infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The VariCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
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    K Number
    K052738
    Device Name
    INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044
    Manufacturer
    VEINRX INC.
    Date Cleared
    2005-12-06

    (67 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEINRX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
    Device Description
    The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
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