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

    BUSSE EXTENSION SET

    K Number: K141285 · Decision Feb 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    4
    Review Days
    279

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    Basic Information

    Device Name
    BUSSE EXTENSION SET
    K Number
    K141285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables
    Date Received
    May 16, 2014
    Decision Date
    February 19, 2015
    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 Busse Hospital Disposables

    K Number Device Name
    K110883 J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
    K093920 BUSSE EPIDURAL CATHETER KIT
    K041464 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER