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

    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE

    K Number: K100446 · Decision Mar 5, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    11
    Review Days
    16

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    Basic Information

    Device Name
    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
    K Number
    K100446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Devon Medical, Inc.
    Date Received
    February 17, 2010
    Decision Date
    March 5, 2010
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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 Devon Medical, Inc.

    K Number Device Name
    K140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit
    K132225 EXTRICARE
    K131464 EXTRICARE NPWT FOOT DRESSING
    K131743 CIRONA DVT FOOT GARMENT
    K130571 DEVON CIRONA 6100 DVT
    K123959 CIRCUFLOW 5150
    K123647 CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
    K102582 ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
    K101523 CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
    K090664 DEVON ACCUBP CUFF
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