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

    APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

    K Number: DEN100026 · Decision Nov 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    4
    Review Days
    342

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    Basic Information

    Device Name
    APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
    K Number
    DEN100026
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    870.3460
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Aptus Endosystems, Inc.
    Date Received
    December 14, 2010
    Decision Date
    November 21, 2011
    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
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    K130677 APTUS HELI-FX AORTIC SECUREMENT SYSTEM
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