BIDIR CATH LG CURVE CEDTB400L US

BIDIR CATH LG CURVE CEDTB400L US
DiamondTemp™ Bidirectional Ablation Catheter - CEDTB400L

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.

• Catheter tip size 2.50mm (7.5Fr)
• Catheter Length: 110.0 Centimeter
• Electrode spacing between distal ring electrode and proximal ring electrode 2mm
• Ring electrode length 1.3mm
• Distal electrode length .6mm
• Outer Diameter: 2.67 Millimeter
• Composite tip electrode length 4.1mm
• Tip Bend Radius: 63.0 Millimeter
• Electrode spacing between composite electrode and distal ring electrode 3.5mm
• Electrode spacing between distal electrode and proximal electrode .5mm

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00763000536671

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