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

    RUSCH POLYFLEX STENT KIT

    K Number: K013266 · Decision Nov 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    43
    Review Days
    57

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    Basic Information

    Device Name
    RUSCH POLYFLEX STENT KIT
    K Number
    K013266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rusch Intl.
    Date Received
    October 1, 2001
    Decision Date
    November 27, 2001
    Product Code
    NYT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NYT Prosthesis, Tracheal, Expandable, Polymeric

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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
    K023918 RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    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
    Search all 43 clearances from Rusch Intl. →