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

    DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)

    K Number: K071202 · Decision Nov 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    2
    Review Days
    213

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    Basic Information

    Device Name
    DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
    K Number
    K071202
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Dermaport, Inc.
    Date Received
    May 1, 2007
    Decision Date
    November 30, 2007
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, Implanted

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    Other Clearances by Dermaport, Inc.

    K Number Device Name
    K091760 DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)