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

    BUSSE EPIDURAL CATHETER

    K Number: K070465 · Decision Jul 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    31
    Review Days
    153

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    Basic Information

    Device Name
    BUSSE EPIDURAL CATHETER
    K Number
    K070465
    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, Inc.
    Date Received
    February 16, 2007
    Decision Date
    July 19, 2007
    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, Inc.

    K Number Device Name
    K120002 I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
    K093909 BUSSE SURGICAL DRAPES IV
    K092212 BUSSE SURGICAL DRAPES III
    K082297 BUSSE SURGICAL DRAPE
    K073222 MODIFICATION TO:SPECIALTY NEEDLES
    K063018 GLASS LOSS OF RESISTANCE SYRINGE
    K061394 SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
    K061570 I-STYLE BONE MARROW ASPIRATION NEEDLE
    K052843 BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
    K032432 BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
    Search all 31 clearances from Busse Hospital Disposables, Inc. →