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

    CARDIAC CATHETERIZATION TRAY

    K Number: K931560 · Decision Jul 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    16
    Review Days
    468

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    Basic Information

    Device Name
    CARDIAC CATHETERIZATION TRAY
    K Number
    K931560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Clinipad Corp.
    Date Received
    March 30, 1993
    Decision Date
    July 11, 1994
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Clinipad Corp.

    K Number Device Name
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    K932016 TRACHEOSTOMY CARE TRAY
    K862562 PUNCH BIOPSY KIT
    K862563 TRACHEOSTOMY CLEANSING SOLUTION
    K833075 WET DRESSING KIT
    K833432 CATHETER INSERTION KIT
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