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

    PlasmaFlow

    K Number: K160318 · Decision Apr 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    PlasmaFlow
    K Number
    K160318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Manamed, Inc.
    Date Received
    February 5, 2016
    Decision Date
    April 1, 2016
    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 Manamed, Inc.

    K Number Device Name
    K231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)
    K222098 ManaSport+
    K210284 ManaSport
    K211253 PlasmaWave
    K200353 ManaFlow
    K200351 PlasmaFlight