8.5 FR VARIPULSE™ Bi
VARIPULSE™ Bi-Directional Catheter - D141201
Device Description
A flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is designed to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device.
Environmental Conditions
- Do not use if package is opened
- Do not use if package is damaged
- Keep Dry
- Keep away from sunlight
- 77.00
- 41.00
- 25.00
- 5.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QZI
Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Device Class: 3
Physical State: The device is an ablation catheter that features electrodes through which pulsed electric fields are 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: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Heart
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 10846835025460
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
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