Product Overview

DiamondTemp™ FASTR RF Generator - CEDTG200

Device Description

An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -22.00
  • Special Storage Condition, Specify
    • Keep dry
  • Storage Environment Temperature - Degrees Fahrenheit
    • 86.00
    • 59.00

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: OAE

    Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    Device Class: 3

    Physical State: The device is an ablation catheter that features electrodes through which thermal energy is 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: Y

    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: 00763000482190

    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

    Educational Resources