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

    SILVERTORQUE CARDIAC CATHETERS

    K Number: K840763 · Decision Jun 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    5
    Review Days
    111

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    Basic Information

    Device Name
    SILVERTORQUE CARDIAC CATHETERS
    K Number
    K840763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Surgimed Corp.
    Date Received
    February 23, 1984
    Decision Date
    June 13, 1984
    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 Surgimed Corp.

    K Number Device Name
    K851157 SURGIMED - SURGICAL BLADES
    K840762 SILVERTORQUE CEREBRAL CATHETER
    K840761 SILVERTORQUE VISCERAL CATHETER
    K810689 BALLOON CATHETER