BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    CLYDE CORONARY GUIDEWIRE

    K Number: K970528 · Decision Jun 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    CLYDE CORONARY GUIDEWIRE
    K Number
    K970528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schneider (Europe) GmbH
    Date Received
    February 11, 1997
    Decision Date
    June 10, 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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    Other Clearances by Schneider (Europe) GmbH

    K Number Device Name
    K984068 FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
    K982592 DOCKING-EXTENSION WIRE
    K970494 HANNIBAL GUIDEWIRE
    K951109 C-THRU CORONARY GUIDE WIRE