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

    PM2+ System and SmartPICC Stylet

    K Number: K243484 · Decision May 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    4
    Review Days
    202

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    Basic Information

    Device Name
    PM2+ System and SmartPICC Stylet
    K Number
    K243484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Piccolo Medical, Inc.
    Date Received
    November 8, 2024
    Decision Date
    May 29, 2025
    Product Code
    LJS
    Advisory Committee
    General Hospital
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Piccolo Medical, Inc.

    K Number Device Name
    K252792 PM2™ System with ECGuide™ Connector
    K240486 PM2 System and ECGuide Connector
    K200037 Piccolo Medical SmartPICC System