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

    BUSSE EPIDURAL CATHETER KIT

    K Number: K093920 · Decision Aug 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    4
    Review Days
    227

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    Basic Information

    Device Name
    BUSSE EPIDURAL CATHETER KIT
    K Number
    K093920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hospital Disposables
    Date Received
    December 22, 2009
    Decision Date
    August 6, 2010
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Busse Hospital Disposables

    K Number Device Name
    K141285 BUSSE EXTENSION SET
    K110883 J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
    K041464 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER