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510(k) Data Aggregation

    K Number
    K994111
    Device Name
    CELSITE, MODELS ST401L, ST405L
    Manufacturer
    B. BRAUN/MCGAW
    Date Cleared
    2000-01-03

    (28 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN/MCGAW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Celsite® System is recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.
    Device Description
    Not Found
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    K Number
    K983373
    Device Name
    IMPACT BALLOON DILATION CATHETER
    Manufacturer
    B. BRAUN/MCGAW
    Date Cleared
    1999-06-22

    (271 days)

    Product Code
    KNQ
    Regulation Number
    876.5365
    Why did this record match?
    Applicant Name (Manufacturer) :

    B. BRAUN/MCGAW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impact balloon dilation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation theropy.
    Device Description
    Not Found
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