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

    FINDRWIRZ GUIDE WIRE SYSTEM

    K Number: K080364 · Decision Aug 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    182

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    Basic Information

    Device Name
    FINDRWIRZ GUIDE WIRE SYSTEM
    K Number
    K080364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentreheart, Inc.
    Date Received
    February 11, 2008
    Decision Date
    August 11, 2008
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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