đź“‹ FDA Reference
venatech r lp vena cava filter system and venatech r convertible vena cava filter system
B. Braun Medical
Summary: The Venatech R LP Vena Cava Filter System is a medical device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K240578 ↗
Decision Date
July 31, 2024
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Venatech R LP Vena Cava Filter System, manufactured by B. Braun Medical, received FDA clearance through the 510k pathway on July 31, 2024. It is classified as a Class 2 device under product code DTK.
What It Is
The Venatech R LP Vena Cava Filter System is designed to capture emboli (blood clots) in the inferior vena cava (IVC), preventing them from reaching the lungs and causing a pulmonary embolism. The filter is typically inserted via a minimally invasive procedure, often through a femoral or jugular vein approach. The convertible version allows for potential retrieval or conversion to a permanent filter, offering flexibility in patient management.
Clinical Applications
This device is commonly used in patients who are at high risk for pulmonary embolism but cannot be managed with anticoagulation therapy. It is frequently utilized in trauma patients, those undergoing major surgery, or patients with a history of deep vein thrombosis. Interventional radiologists and vascular surgeons typically perform the procedure in a hospital or surgical center setting.
Indications for Use
The Venatech R LP Vena Cava Filter is indicated for patients who are at risk of pulmonary embolism and cannot be treated with anticoagulants. It is suitable for both temporary and permanent use, depending on the patient's condition and risk factors.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the patient's venous anatomy and to follow proper insertion techniques to minimize complications. The convertible feature allows for retrieval if the patient's condition changes.
Frequently Asked Questions
What is the Venatech R LP Vena Cava Filter used for?
It 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?
It is indicated for patients at risk of pulmonary embolism who cannot be treated with 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.