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

    VASOPRESS SUPREME MINI MODEL VP500DM

    K Number: K101915 · Decision Aug 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    VASOPRESS SUPREME MINI MODEL VP500DM
    K Number
    K101915
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Compression Therapy Concepts, Inc.
    Date Received
    July 9, 2010
    Decision Date
    August 6, 2010
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Compression Therapy Concepts, Inc.

    K Number Device Name
    K112838 VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
    K061814 VASOPRESS DVT SYSTEM, MODEL VP500D
    K061967 SCD GARMENT, MODEL VP530
    K000147 CTC DVT-1 CALF GARMENT, MODEL DVT-1