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

    Reprocessed Agilis NxT Steerable Introducer

    K Number: K250305 · Decision Jan 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    338

    Basic Information

    Device Name
    Reprocessed Agilis NxT Steerable Introducer
    K Number
    K250305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Health
    Date Received
    February 3, 2025
    Decision Date
    January 7, 2026
    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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