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

    ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE

    K Number: K110553 · Decision Mar 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    1
    Review Days
    18

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    Basic Information

    Device Name
    ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
    K Number
    K110553
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asahi Intecc USA, Inc.
    Date Received
    February 28, 2011
    Decision Date
    March 18, 2011
    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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