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lifeline tle 476-04
Intermedics
Summary: The Lifeline TLE 476-04 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by trapping blood clots. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K843393 ↗
Decision Date
September 24, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline TLE 476-04 was cleared through the FDA 510(k) pathway on September 24, 1984, by Intermedics. It is classified as a Class III device under product code DTB.
What It Is
The Lifeline TLE 476-04 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 captures clots while allowing normal blood flow, providing a critical intervention for patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in patients who are at high risk for pulmonary embolism and cannot be managed with anticoagulation therapy alone. It is often employed in settings such as hospitals and specialized vascular centers. Interventional radiologists and vascular surgeons typically perform the implantation procedure, which is minimally invasive and involves accessing the IVC via a catheter.
Indications for Use
The FDA indications suggest that the Lifeline TLE 476-04 is used for patients at risk of developing pulmonary embolism, particularly those who cannot take blood thinners or have contraindications to anticoagulation therapy. It is suitable for patients with a history of deep vein thrombosis or other clotting disorders.
Practical Considerations
Clinicians should consider the size of the IVC and the patient's anatomy when selecting the appropriate filter size. The device is compatible with standard catheterization techniques, and proper imaging guidance is recommended during placement to ensure optimal positioning and function.
Frequently Asked Questions
What is Lifeline TLE 476-04 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 radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients at risk of pulmonary embolism who cannot take anticoagulants.
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.