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

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

    K Number: K062531 · Decision Sep 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    35
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
    K Number
    K062531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Corp., A Johnson & Johnson Co.
    Date Received
    August 29, 2006
    Decision Date
    September 22, 2006
    Product Code
    NTE
    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
    NTE Temporary Carotid Catheter For Embolic Capture

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    Other Clearances by Cordis Corp., A Johnson & Johnson Co.

    K Number Device Name
    K140438 MICRO GUIDE CATHETER ELITE
    K131225 ADROIT GUIDING CATHETER
    K091077 OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
    K083814 OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120