JETi™ 8F Catheter


Product Overview

JETi™ 8F Catheter
JETi™ - WV088F


Device Description

A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 60.00
    • -30.00
  • Special Storage Condition, Specify
    • Store in a dry and dark place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
  • Storage Environment Temperature - Degrees Celsius
    • 25.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QEZ

    Device Name: Aspiration Thrombectomy Catheter

    Device Class: 2

    Physical State: Peripheral and/or coronary catheter

    Definition: To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: Y

    Gmp Exempt Flag: removed thrombus from the vasculature

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Peripheral and/or coronary vasculature

    Regulation Number: 870.5150

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 08717648353260

    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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