đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in procedures involving inferior vena cava filters, as described by the available device record.
Clinical Applications
- Use during hospital-based procedures involving IVC filters.
- Use in conjunction with IVC-filter procedures performed by interventional radiology or cardiology teams.
Practical Considerations
- The available record does not specify the electrode design, dimensions, connector, or compatibility with particular IVC-filter systems.
- Use should follow the manufacturer’s instructions and the complete FDA-cleared labeling; the available summary does not establish specific placement, adjustment, or retrieval techniques.
- MRI safety is not established in the available record. Do not assume the electrodes are MR Safe or MR Conditional without verified labeling.
- The procedure team should confirm the intended use, vascular access technique, device compatibility, and precautions before use.
- Contraindications, sterilization requirements, and expected service life should be taken from the original labeling or manufacturer documentation.
Procedures that use this device
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.