BAND 638BL38 CG FUTURE 10L


Product Overview

BAND 638BL38 CG FUTURE 10L
CG FUTURE® - 638BL38


Device Description

A circular band intended to be implanted in the heart to support a mitral valve annulus for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Away From Heat
  • Special Storage Condition, Specify
    • Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
  • Special Storage Condition, Specify
    • Keep Dry

  • Device Sizes

  • Lumen/Inner Diameter: 38.0 Millimeter
    • Lumen/Inner Diameter: 38.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KRH

    Device Name: Ring, Annuloplasty

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: 870.3800

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00613994521088

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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