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

    Steripath Micro Blood Collection System

    K Number: K200661 · Decision Oct 8, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    2
    Review Days
    210

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    Basic Information

    Device Name
    Steripath Micro Blood Collection System
    K Number
    K200661
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magnolia Medical Technologies, Inc.
    Date Received
    March 12, 2020
    Decision Date
    October 8, 2020
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    Other Clearances by Magnolia Medical Technologies, Inc.

    K Number Device Name
    K192247 Steripath Gen2 Blood Collection System