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

    GORE BALLOON SHEATH

    K Number: K070770 · Decision Jun 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    163
    Review Days
    101

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    Basic Information

    Device Name
    GORE BALLOON SHEATH
    K Number
    K070770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    March 20, 2007
    Decision Date
    June 29, 2007
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

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    Other Clearances by W. L. Gore & Associates, Inc.

    K Number Device Name
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    K232312 GORE® PROPATEN® Vascular Graft
    K233551 GORE® ACUSEAL Vascular Graft
    K231505 GORE® ACUSEAL Vascular Graft
    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K173333 GORE ENFORM Biomaterial
    K163576 GORE SYNECOR Preperitoneal Biomaterial
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