PROGREAT Microcatheter System


Product Overview

PROGREAT Microcatheter System
PROGREAT - MC*PB2413Y


Device Description

A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

  • Device Sizes

  • Outer Diameter: 0.80 Millimeter
  • Clinically Relevant Size 1 is relative to catheter distal end. And other Clinically Relevant Sizes are relative to catheter shaft.
  • Length: 130 Centimeter
    • Outer Diameter: 0.80 Millimeter
    • Clinically Relevant Size 1 is relative to catheter distal end. And other Clinically Relevant Sizes are relative to catheter shaft.
    • Length: 130 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DQO

    Device Name: Catheter, Intravascular, Diagnostic

    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: 870.1200

    Third Party Flag: Y

    Medical Specialty: CV


    Code: KRA

    Device Name: Catheter, Continuous Flush

    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: 870.1210

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 54987350781210

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04987350781215

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04987350781215

    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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