- Physicians Office Resource

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

Device Description

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.

Environmental Conditions

Special Storage Condition, Specify

Keep dry

Special Storage Condition, Specify

Keep away from sunlight

Device Sizes

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

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 Sterilization

Device Sterile: True

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: 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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.