Product Overview

APTUS Heli-FX® - SA-85

Device Description

A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

Environmental Conditions

  • Special Storage Condition, Specify
    • (10-40° C)(30-75% RH)
  • Special Storage Condition, Specify
    • Keep Dry

  • Device Sizes

  • 86 CM Sheath Working Length
    • 86 CM Sheath Working Length

    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: OTD

    Device Name: Endovascular Suturing System

    Device Class: 2

    Physical State: The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.

    Definition: Provides fixation and sealing between and endovascular graft and the native artery.

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses a metallic implant, delivered through a catheter-based system, to affix the material of an endovascular graft to native vessel

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: The implant is to be placed at the proximal end of an aortic aneurysm.

    Regulation Number: 870.3460

    Third Party Flag: N

    Medical Specialty: CV

    Device Identifiers

    Device Id: 00643169647695

    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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