Embolic Protection Device


Product Overview

Embolic Protection Device
SpiderFX - SPD2-US-070-320


Device Description

A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep dry; Avoid direct sunlight

  • Device Sizes

  • Outer Diameter: .014 Inch
  • Length: 320 Centimeter
  • Outer Diameter: 7 Millimeter
    • Outer Diameter: .014 Inch
    • Length: 320 Centimeter
    • Outer Diameter: 7 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NFA

    Device Name: Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

    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: N

    Target Area: N/A

    Regulation Number: 870.1250

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00821684040379

    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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