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model 6208 6209 6210 6211 6212 6214 pli s
Medtronic Vascular
Summary: The Model 6208-6214 PLI S is an IVC filter used to prevent pulmonary embolism by capturing blood clots. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K890045 ↗
Decision Date
January 30, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device received FDA clearance through the 510(k) pathway on January 30, 1989. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The Model 6208-6214 PLI S is a series of inferior vena cava (IVC) filters designed to trap embolic particles such as blood clots, preventing them from reaching the lungs and causing a pulmonary embolism. These filters are typically inserted via a catheter through a vein in the groin or neck and positioned in the IVC. The device is made of biocompatible materials and is designed to allow normal blood flow while capturing clots.
Clinical Applications
IVC filters like the Model 6208-6214 PLI S are commonly used in patients who are at high risk for pulmonary embolism and cannot be treated with anticoagulation therapy. They are often used in trauma patients, those with deep vein thrombosis, or individuals undergoing major surgery. The device is primarily utilized in hospital settings by interventional radiologists and vascular surgeons.
Indications for Use
This device is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective. It is suitable for individuals with a history of venous thromboembolism or those undergoing procedures that increase clot risk.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the patient's IVC diameter and to follow proper insertion techniques to minimize complications. Retrieval of the filter, if designed for temporary use, should be planned based on the patient's condition and risk factors.
Frequently Asked Questions
What is Model 6208-6214 PLI S 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?
The device is indicated for patients at risk of pulmonary embolism, especially when anticoagulation therapy is not suitable.
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.