CATHETER 990063-015 ACHIEVE 15MM US


Product Overview

CATHETER 990063
ACHIEVE™ - 990063-015


Device Description

A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 58.00
    • -35.00
  • Special Storage Condition, Specify
    • Keep Dry
  • Special Storage Condition, Specify
    • Keep away from heat and sunlight
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • N/A
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

  • Effective Length 146 cm
  • Catheter Size 3.3 Fr
  • Electrode Spacing 4 mm
  • Overall Length 165 cm
  • Tip Diameter 15 mm
    • Effective Length 146 cm
    • Catheter Size 3.3 Fr
    • Electrode Spacing 4 mm
    • Overall Length 165 cm
    • Tip Diameter 15 mm


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DRF

    Device Name: Catheter, Electrode Recording, Or Probe, Electrode Recording

    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: 870.1220

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00643169489080

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos