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

    APTUS HELI-FX AORTIC SECUREMENT SYSTEM

    K Number: K130677 · Decision Apr 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    APTUS HELI-FX AORTIC SECUREMENT SYSTEM
    K Number
    K130677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3460
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aptus Endosystems, Inc.
    Date Received
    March 13, 2013
    Decision Date
    April 12, 2013
    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.

    K Number Device Name
    K140036 APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
    K121168 APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
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