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

    RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS

    K Number: K023918 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    43
    Review Days
    123

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    Basic Information

    Device Name
    RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    K Number
    K023918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rusch Intl.
    Date Received
    November 25, 2002
    Decision Date
    March 28, 2003
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Rusch Intl.

    K Number Device Name
    K033023 INTERMITTENT URETHRAL CATHETERS
    K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
    K023964 RUSCH MICROLARYNGEAL TUBE
    K021540 RUSCH EDGAR TUBE
    K021764 RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
    K020714 RUSCH FLONEIL; FLOCATH INTROGEL
    K010798 RUSCH CANTOR TUBE
    K010797 RUSCH MILLER-ABBOTT TUBE
    K013872 RUSCH MEMORY BAG
    Search all 43 clearances from Rusch Intl. →