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

    APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH

    K Number: K121168 · Decision Aug 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    4
    Review Days
    113

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    Basic Information

    Device Name
    APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
    K Number
    K121168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3460
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aptus Endosystems, Inc.
    Date Received
    April 17, 2012
    Decision Date
    August 8, 2012
    Product Code
    OTD
    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
    OTD Endovascular Suturing System

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    Other Clearances by Aptus Endosystems, Inc.

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    K130677 APTUS HELI-FX AORTIC SECUREMENT SYSTEM
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