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five-year sterile packaging shelf life
Daig
Summary: This is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by trapping blood clots. It is used by interventional radiologists and vascular surgeons in patients at risk of thromboembolic events.
FDA Clearance Information
Pathway
510K
Number
K892528 ↗
Decision Date
January 18, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The IVC Filter by Daig was cleared via the FDA 510k pathway on January 18, 1990. It is a Class 3 medical device, indicating a high level of regulatory control.
What It Is
The IVC Filter is a medical device designed to prevent pulmonary embolism by capturing blood clots that travel from the lower extremities to the lungs. It is typically inserted into the inferior vena cava through a minimally invasive procedure. The device is made to withstand the body's internal environment for an extended period, as indicated by its five-year sterile packaging shelf life.
Clinical Applications
IVC filters are commonly used in patients who have contraindications to anticoagulation therapy or have experienced recurrent venous thromboembolism despite anticoagulation. They are often placed in hospital settings by interventional radiologists or vascular surgeons. The device is particularly useful in trauma patients, those undergoing major surgery, or individuals with a history of deep vein thrombosis.
Indications for Use
The FDA indications suggest that this device is used for patients at risk of developing pulmonary embolism, especially when anticoagulation therapy is not suitable. It is intended for individuals with a history of blood clots or those undergoing procedures that increase clot risk.
Practical Considerations
IVC filters come in various sizes to accommodate different patient anatomies. Proper placement technique is crucial to ensure efficacy and minimize complications. Compatibility with imaging modalities like fluoroscopy is essential for accurate deployment.
Related Literature
The linked study investigated the impact of a ReMIND diet intervention on sarcopenia, cognitive frailty, and nutritional status in older adults. Although the study's abstract is not available, it likely explored dietary modifications to improve health outcomes in this population. The lack of an abstract and publication year limits the ability to draw definitive conclusions from this study.
Frequently Asked Questions
What is the IVC Filter 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 commonly use this device.
What are the FDA-cleared indications?
For patients at risk of pulmonary embolism, especially 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.