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

    SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS

    K Number: K964859 · Decision Feb 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    109
    Review Days
    68

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    Basic Information

    Device Name
    SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
    K Number
    K964859
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    December 4, 1996
    Decision Date
    February 10, 1997
    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 Scimed Life Systems, Inc.

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    K973945 LUGE GUIDE WIRE
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    K965023 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
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