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

    MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

    K Number: K100789 · Decision Apr 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
    K Number
    K100789
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Evalve, Inc.
    Date Received
    March 22, 2010
    Decision Date
    April 21, 2010
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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    Other Clearances by Evalve, Inc.

    K Number Device Name
    K093866 EVALVE STEERABLE GUIDE CATHETER
    K091596 EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
    K083793 STEERABLE GUIDE CATHETER