SOLOPATH Re-collapsible Balloon Access System


Product Overview

SOLOPATH Re
SOLOPATH - SR-2025


Device Description

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Avoid direct sunlight
  • Special Storage Condition, Specify
    • Do not store at extreme temperature and humidity

  • Device Sizes

  • Inner Diameter: 20 FrenchOuter Diameter: 24 French
  • Nominal Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi
  • Length: 25 Centimeter
    • Inner Diameter: 20 FrenchOuter Diameter: 24 French
    • Nominal Inflation Pressure: 20 atm/bar or 2026 kPa or 294 psi
    • Length: 25 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DYB

    Device Name: Introducer, Catheter

    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: 870.1340

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 50389701012259

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00389701012254

    Package Quantity: 39

    Package Discontinue Date: 11/15/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Carton


    Device Id: 00389701012254

    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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