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

    VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS

    K Number: K112838 · Decision Nov 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    5
    Review Days
    43

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    Basic Information

    Device Name
    VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
    K Number
    K112838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Compression Therapy Concepts, Inc.
    Date Received
    September 28, 2011
    Decision Date
    November 10, 2011
    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
    K101915 VASOPRESS SUPREME MINI MODEL VP500DM
    K061814 VASOPRESS DVT SYSTEM, MODEL VP500D
    K061967 SCD GARMENT, MODEL VP530
    K000147 CTC DVT-1 CALF GARMENT, MODEL DVT-1