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

    VESOFLOW

    K Number: K110977 · Decision Aug 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    4
    Review Days
    140

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    Basic Information

    Device Name
    VESOFLOW
    K Number
    K110977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caremed Supply, Inc.
    Date Received
    April 7, 2011
    Decision Date
    August 25, 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 Caremed Supply, Inc.

    K Number Device Name
    K181217 VesoFlow Lite DVT Compression Device
    K141064 VESOFLOW PLUS DVT COMPRESSION DEVICE
    K122873 VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS