CATH 075402 RF MARINR MCXL W/O CE

CATH 075402 RF MARINR MCXL W/O CE
RF Marinr™ - 075402

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 usable length 110 cm
• Catheter deflectable tip length 55-75 mm
• Electrode spacing 2.5.2 mm
• Catheter size 2.3mm (7 Fr)
• Catheter distal electrode size 4 mm

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LPB

Device Name: Cardiac Ablation Percutaneous Catheter

Device Class: 3

Physical State: N/A

Definition: This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000227722

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