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

    Passio Pump Drainage System

    K Number: K230319 · Decision Nov 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    14
    Applicant Total
    3
    Review Days
    291

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    Basic Information

    Device Name
    Passio Pump Drainage System
    K Number
    K230319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Bearpac Medical
    Date Received
    February 6, 2023
    Decision Date
    November 24, 2023
    Product Code
    PNG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

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    Other Clearances by Bearpac Medical

    K Number Device Name
    K201404 Passio Pump Drainage System
    K190292 Passio Pump Drainage System