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lifeline tle 484-02
Intermedics
Summary: The Lifeline TLE 484-02 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by trapping blood clots. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K843394 ↗
Decision Date
September 24, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline TLE 484-02 was cleared through the FDA 510k pathway on September 24, 1984. Manufactured by Intermedics, it is a Class III device under product code DTB.
What It Is
The Lifeline TLE 484-02 is an IVC filter designed to prevent blood clots from traveling to the lungs, which can cause a pulmonary embolism. It is implanted in the inferior vena cava, the large vein that carries blood from the lower body to the heart. The filter catches clots while allowing normal blood flow, providing a protective measure for patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in patients who have a high risk of developing pulmonary embolism but cannot be treated with anticoagulants. It is often used in trauma patients, those undergoing major surgery, or individuals with a history of deep vein thrombosis. Interventional radiologists and vascular surgeons typically perform the implantation procedure in a hospital setting.
Indications for Use
The FDA indications suggest that the Lifeline TLE 484-02 is used for patients who are at risk of pulmonary embolism, especially when anticoagulation therapy is contraindicated or has failed. It is suitable for patients with venous thromboembolism conditions.
Practical Considerations
When considering this device, clinicians should be aware of the sizing options to ensure proper fit within the patient's vena cava. Compatibility with existing vascular access techniques is crucial, and the procedure requires fluoroscopic guidance for accurate placement.
Frequently Asked Questions
What is Lifeline TLE 484-02 used for?
It is used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiology and vascular surgery specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is not an option.
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.