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    K Number
    K231279
    Device Name
    Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
    Manufacturer
    Ablative Solutions, Inc.
    Date Cleared
    2023-07-05

    (63 days)

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

    Ablative Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peregrine System™ Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.
    Device Description
    The Peregrine System Infusion Catheter is a continuous flush catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 3-7 mm in diameter and is compatible with guide catheters of at least 7F.
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    K Number
    K140637
    Device Name
    PEREGRINE SYSTEM INFUSION CATHETER
    Manufacturer
    ABLATIVE SOLUTIONS, INC.
    Date Cleared
    2014-03-26

    (14 days)

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

    ABLATIVE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.
    Device Description
    The Peregrine System Infusion Catheter is a percutaneous catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 5-7 mm in diameter and is compatible with guide catheters of at least 7F.
    Ask a Question

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