GENERATOR 6800001AM CARDIOBLATE EN

GENERATOR 6800001AM CARDIOBLATE EN
Cardioblate® - 6800001AM

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).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OCL

Device Name: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Device Class: 2

Physical State: The device tip delivers energy to provide cutting, coagulation, and/or ablation of the contacted tissue

Definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device energy source used to provide cutting, coagulation and/or ablation may be radio frequency (RF), cryogenic, laser or ultrasound

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cardiac tissue.

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 00613994299413

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