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510(k) Data Aggregation

    K Number
    K241250
    Device Name
    3DMax Light Mesh
    Manufacturer
    Davol Inc., Subsidiary of C.R. Bard, Inc.
    Date Cleared
    2024-06-14

    (42 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Davol Inc., Subsidiary of C.R. Bard, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K233402
    Device Name
    Bard 3DMax Mesh
    Manufacturer
    Davol Inc., Subsidiary of C.R. Bard, Inc.
    Date Cleared
    2023-11-01

    (28 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Davol Inc., Subsidiary of C.R. Bard, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
    Device Description
    The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
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