BareWire Distal Access Filter Delivery Wire 190 cm


Product Overview

BareWire Distal Access Filter Delivery Wire 190 cm
BAREWIRE - 22439-19


Device Description

A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store in a cool, dark, dry area.

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NTE

    Device Name: Temporary Carotid Catheter For Embolic Capture

    Device Class: 2

    Physical State: N/A

    Definition: This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i

    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: N

    Target Area: N/A

    Regulation Number: 870.1250

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 28717648137789

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 08717648137785

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Case


    Device Id: 08717648137785

    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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