Celsius ThermoCool

Celsius ThermoCool - DI7TCFLRT

A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OAD

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

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 flutter.

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 flutter.

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 Id: 10846835000450

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