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l-12 l-21 and l-22 electrodes
Coratomic
Summary: The l-12, l-21, and l-22 electrodes by Coratomic are used in medical procedures involving IVC filters. They are typically utilized by interventional radiologists and cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K780569 ↗
Decision Date
June 14, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The l-12, l-21, and l-22 electrodes, manufactured by Coratomic, were cleared via the FDA 510(k) pathway on June 14, 1978. They are classified as Class III medical devices under product code DTB.
What It Is
These electrodes are specialized medical devices used in conjunction with inferior vena cava (IVC) filters. They function by facilitating the placement, adjustment, or removal of IVC filters, which are used to prevent pulmonary embolism by capturing blood clots. The electrodes are designed to ensure precise control and positioning during these procedures.
Clinical Applications
The electrodes are commonly used in interventional radiology and cardiology, particularly in procedures involving the insertion or retrieval of IVC filters. These procedures are typically performed in hospital settings on patients who are at risk of developing pulmonary embolism, such as those with deep vein thrombosis or those who cannot tolerate anticoagulation therapy.
Indications for Use
These electrodes are indicated for use in procedures involving IVC filters, which are primarily used to prevent blood clots from traveling to the lungs in patients at risk of pulmonary embolism. They are suitable for patients who require temporary or permanent protection from embolic events.
Practical Considerations
The electrodes are compatible with standard IVC filter systems and are available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with the specific technique for electrode use, including proper insertion and retrieval methods, to ensure optimal outcomes.
Frequently Asked Questions
What is l-12, l-21, l-22 electrodes used for?
These electrodes are used in procedures involving the placement, adjustment, or removal of IVC filters to prevent pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use these electrodes in hospital settings.
What are the FDA-cleared indications?
These electrodes are indicated for use in procedures involving IVC filters to prevent blood clots from reaching the lungs in patients at risk of pulmonary embolism.
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.