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ensite velocity surface electrode kit
St Jude Medical
Summary: The Ensite Velocity Surface Electrode Kit is a medical device used for tumor ablation procedures. It is typically utilized by cardiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K160186 ↗
Decision Date
October 7, 2016
Product Code
DQK
Device Class
Class 2
Evidence
0 studies
The Ensite Velocity Surface Electrode Kit was cleared through the FDA 510k pathway on October 7, 2016. Manufactured by St Jude Medical, it is classified as a Class 2 device under product code DQK.
What It Is
The Ensite Velocity Surface Electrode Kit is designed for use in tumor ablation procedures. It consists of electrodes that help in mapping and guiding the ablation process. This device works by providing precise localization and targeting of tumor tissues, aiding in effective treatment.
Clinical Applications
This device is commonly used in procedures involving tumor ablation, particularly in oncology and cardiology settings. It is employed in hospitals and specialized clinics where precise tumor targeting is crucial. The device is suitable for adult patients undergoing minimally invasive tumor treatments.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures that require precise tumor localization and ablation. It is suitable for patients with tumors that are accessible via minimally invasive techniques.
Practical Considerations
The Ensite Velocity Surface Electrode Kit is typically compatible with other ablation systems. Clinicians should ensure proper electrode placement for accurate mapping. The device is available in various sizes to accommodate different patient anatomies.
Frequently Asked Questions
What is Ensite Velocity Surface Electrode Kit used for?
It is used for precise localization and ablation of tumors in medical procedures.
What specialties typically use this device?
Cardiology and oncology specialists commonly use this device in clinical settings.
What are the FDA-cleared indications?
It is indicated for use in tumor ablation procedures requiring precise targeting and localization.
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.