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

    HIGH-PRESSURE CONNECTOR TUBE

    K Number: K904212 · Decision Dec 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    43
    Review Days
    82

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    Basic Information

    Device Name
    HIGH-PRESSURE CONNECTOR TUBE
    K Number
    K904212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Medical
    Date Received
    September 12, 1990
    Decision Date
    December 3, 1990
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Mallinckrodt Medical

    K Number Device Name
    K082520 SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
    K051416 SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
    K972258 HI-CARE CLOSED SUCTION SYSTEM
    K971267 SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
    K963732 PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
    K955721 CUFFED OROPHARYNGEAL AIRWAY (COPA)
    K965132 HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
    K962045 ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
    K962173 SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
    K955680 SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
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