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510(k) Data Aggregation

    K Number
    K213442
    Device Name
    Extroducer Infusion Catheter System
    Manufacturer
    Smartwise Sweden AB
    Date Cleared
    2022-06-10

    (228 days)

    Product Code
    KRA
    Regulation Number
    870.1210
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    Applicant Name (Manufacturer) :

    Smartwise Sweden AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.
    Device Description
    The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to perivascular tissue of adult patients. At the selected site, the device is used to penetrate through the vascular wall into the tissue requiring treatment. The diagnostic or therapeutic solution is then delivered through the device. The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes. The Extroducer™ Infusion catheter system consists of two main parts: An infusion needle with a needle hub and radiopaque marker and An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use.
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