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

    RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE

    K Number: K971281 · Decision Oct 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    40
    Review Days
    185

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    Basic Information

    Device Name
    RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
    K Number
    K971281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medcomp
    Date Received
    April 7, 1997
    Decision Date
    October 9, 1997
    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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