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    K Number
    K242420
    Device Name
    pNOVUS 21 Microcatheter
    Manufacturer
    phenox Ltd
    Date Cleared
    2024-11-12

    (89 days)

    Product Code
    DQO, QJP
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    phenox Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pNOVUS 21 Microcatheter is indicated for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. It is not intended for use in peripheral or coronary vasculature.
    Device Description
    The pNOVUS 21 Microcatheter (pNOVUS 21) is a single use microcatheter, supplied sterile using ethylene oxide (EtO), in a packing hoop, within a sealed pouch and shelf carton configuration. An introducer sheath and shaping mandrel are supplied on a backing card inside the pouch. The packaging is designed to facilitate ease of handling and aseptic presentation of the device. The pNOVUS 21 Microcatheter is a variable stiffness single lumen catheter. The pNOVUS 21 has a radiopaque marker on the distal end to facilitate fluoroscopic visualization, and a luer hub on the proximal end to facilitate the infusion of diagnostic agents and the smooth transfer of other devices (e.g., guidewires) into the inner lumen of the microcatheter. The distal end of the microcatheter's external surface has a hydrophilic coating applied for increased lubricity during use. The pNOVUS 21 has a straight tip. Steam shaping of the distal tip allows for one-time customizing of the tip shape. There are two models of the pNOVUS 21 Microcatheter, the device model # are: - PNOV-21-160 - PNOV-21-150 The pNOVUS 21 Microcatheter is intended for use with compatible accessories, such as guidewires and guide catheters, in the delivery of interventional devices and infusion of diagnostic agents, such as contrast media, into the neuro vasculature during diagnostic and/or therapeutic procedures. pNOVUS 21 is generally inserted either through a sheath or guide-catheter.
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    K Number
    K221279
    Device Name
    pNOVUS 21 Microcatheter
    Manufacturer
    phenox Ltd
    Date Cleared
    2022-11-28

    (209 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    phenox Ltd

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