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

    Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer

    K Number: K250314 · Decision Dec 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    23
    Review Days
    318

    Basic Information

    Device Name
    Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
    K Number
    K250314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    February 4, 2025
    Decision Date
    December 19, 2025
    Product Code
    PNE
    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
    PNE Reprocessed Catheter Introducer

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