📋 FDA Reference
Varipulse Catheter Trupulse Generator Sterile Interface Cable Ngen Pump
Biosense Webster
Summary: The Varipulse Catheter Trupulse Generator is a medical device used for tumor ablation. It is primarily used by interventional radiologists and oncologists to treat tumors in various clinical settings.
FDA Clearance Information
Pathway ?
PMA
Number ?
P240006 ↗
Decision Date ?
January 2, 2026
Product Code ?
QZI
Device Class ?
Class 3
Evidence ?
0 studies
The Varipulse Catheter Trupulse Generator, manufactured by Biosense Webster, received FDA clearance under PMA P240006 on January 2, 2026. It is classified as a Class 3 medical device.
What It Is
The Varipulse Catheter Trupulse Generator is an advanced medical device designed for the ablation of tumors. It utilizes a catheter-based system to deliver precise energy pulses to target and destroy tumor tissues. The device includes a sterile interface cable and an ngen pump, which are integral to its operation, ensuring controlled and effective energy delivery.
FDA-Cleared Indications
- Addition of an alternate supplier for a component used in the manufacture of the VARIPULSE Interface Cable.
Clinical Applications
This device is commonly used in interventional oncology for the treatment of solid tumors. It is particularly useful in minimally invasive procedures where precision is crucial, such as in liver or kidney tumor ablations. The device is typically employed in hospital settings, often in interventional radiology suites, and is used on adult patients who are candidates for tumor ablation therapy.
Practical Considerations
- This FDA record concerns a manufacturing-supplier change for a cable component, not a new clinical indication.
- Confirm that the cable is the correct sterile interface component for the compatible VARIPULSE system before use.
- Follow the manufacturer's instructions for sterile handling, connection, inspection, and disposal.
- Do not infer MRI safety, catheter sizing, pump compatibility, or generator performance from this FDA record; consult the current device labeling.
- The FDA indication provided does not specify patient selection, treatment anatomy, procedure duration, or contraindications.
Frequently Asked Questions
What is the Varipulse Catheter Trupulse Generator used for?
It is used for the ablation of tumors, delivering precise energy to destroy tumor tissues.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for tumor ablation, with a focus on ensuring reliable component supply for its interface cable.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.