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

    EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER

    K Number: K110133 · Decision Jun 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    143

    Basic Information

    Device Name
    EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
    K Number
    K110133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CREGANNA-TACTX MEDICAL
    Date Received
    January 18, 2011
    Decision Date
    June 10, 2011
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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    Other Clearances by CREGANNA-TACTX MEDICAL

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