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

    NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

    K Number: K220171 · Decision Jul 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    161

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    Basic Information

    Device Name
    NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
    K Number
    K220171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Northeast Scientific, Inc.
    Date Received
    January 21, 2022
    Decision Date
    July 1, 2022
    Product Code
    QTF
    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
    QTF Reprocessed Atherectomy Catheter

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