IMPRA® ePTFE Vascular Graft, Flex™ Thinwall, 8 mm x 70 cm


Product Overview

IMPRA® ePTFE Vascular Graft, Flex™ Thinwall, 8 mm x 70 cm
IMPRA® ePTFE Vascular Grafts - F7008TW


Device Description

An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.


Environmental Conditions

No Data Available


Device Sizes

  • Internal Diameter, 8 Millimeter
  • Length: 70 Centimeter
    • Internal Diameter, 8 Millimeter
    • Length: 70 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DYF

    Device Name: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

    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: 870.3450

    Third Party Flag: N

    Medical Specialty: CV


    Code: DSY

    Device Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    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: 870.3450

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00801741023163

    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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