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Elamedical
Summary: The focus t41 series by Elamedical is an FDA-cleared IVC filter device used to prevent pulmonary embolism. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K904255 ↗
Decision Date
January 18, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The focus t41 series received FDA clearance through the 510k pathway on January 18, 1991. Manufactured by Elamedical, it is classified as a Class III device under product code DTB.
What It Is
The focus t41 series is a set of inferior vena cava (IVC) filters designed to prevent blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. These filters are implanted in the IVC, the large vein that carries blood from the lower body to the heart. The device works by catching clots while allowing normal blood flow, providing a mechanical barrier to emboli.
Clinical Applications
IVC filters like the focus t41 series are commonly used in patients who are at high risk for pulmonary embolism but cannot take anticoagulants. They are often utilized in trauma patients, those with deep vein thrombosis, or individuals undergoing certain surgeries. The device is typically placed in a hospital setting by interventional radiologists or vascular surgeons.
Indications for Use
The FDA indications for the focus t41 series include preventing pulmonary embolism in patients who have contraindications to anticoagulation therapy. It is suitable for individuals with a history of thromboembolic disease or those undergoing procedures that increase embolic risk.
Practical Considerations
The focus t41 series comes in various sizes to accommodate different patient anatomies. Compatibility with imaging techniques such as fluoroscopy is essential for accurate placement. Clinicians should be aware of potential complications like filter migration or thrombosis.
Frequently Asked Questions
What is focus t41 used for?
The focus t41 series is used to prevent pulmonary embolism by capturing 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?
The device is indicated for preventing pulmonary embolism in patients 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.