BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

    K Number: K250592 · Decision May 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    74

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    Basic Information

    Device Name
    NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
    K Number
    K250592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Northeast Scientific, Inc.
    Date Received
    February 27, 2025
    Decision Date
    May 12, 2025
    Product Code
    OWQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OWQ Reprocessed Intravascular Ultrasound Catheter

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    Other Clearances by Northeast Scientific, Inc.

    K Number Device Name
    K223026 NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
    K220171 NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
    K200195 NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
    K090661 NES REPROCESSED VARICOSE VEIN RF CATHETER
    K060676 NES REPROCESSED ENDOSCOPIC TROCAR