REMOTE CONTROL PSRC101 PFA 25FT US


Product Overview

REMOTE CONTROL PSRC101 PFA 25FT US
PulseSelect™ - PSRC101


Device Description

A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to allow a healthcare provider to control the operational functions of a cardiac irreversible electroporation system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep Dry

  • Device Sizes

  • Length: 25.0 Feet
    • Length: 25.0 Feet


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: QZI

    Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    Device Class: 3

    Physical State: The device is an ablation catheter that features electrodes through which pulsed electric fields are delivered.

    Definition: For the treatment of atrial fibrillation.

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The ablation catheter delivers energy to the specific region of the heart in order to create lesions that will treat the patient of atrial fibrillation.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Heart

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00763000617752

    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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