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cordis multifilar pervenous ventric ld
Cordis
Summary: The Cordis Multifilar Pervenous Ventric LD is a Class III medical device used primarily in the placement of inferior vena cava (IVC) filters. It is utilized by interventional radiologists and vascular surgeons to prevent pulmonary embolism in patients at risk.
FDA Clearance Information
Pathway
510K
Number
K810202 ↗
Decision Date
February 5, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cordis Multifilar Pervenous Ventric LD was cleared through the FDA 510(k) pathway on February 5, 1981. Manufactured by Cordis, it is classified as a Class III device under product code DTB.
What It Is
The Cordis Multifilar Pervenous Ventric LD is a specialized catheter designed for the placement of IVC filters. These filters are used to capture blood clots before they can travel to the lungs, thereby preventing pulmonary embolism. The device is constructed with multiple filars to enhance its stability and performance during insertion and positioning.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for patients who are at high risk of developing pulmonary embolism and cannot be managed with anticoagulation therapy alone. It is particularly useful in trauma patients, those with deep vein thrombosis, and individuals undergoing major surgeries. The device is typically used in hospital settings, including operating rooms and interventional suites.
Indications for Use
The FDA indications for the Cordis Multifilar Pervenous Ventric LD involve its use in patients who require protection against pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective. It is suitable for patients with a history of venous thromboembolism or those undergoing procedures that increase the risk of clot formation.
Practical Considerations
Clinicians should be aware of the device's compatibility with various IVC filter models and ensure proper sizing based on patient anatomy. The insertion technique requires familiarity with percutaneous access and fluoroscopic guidance to ensure accurate placement. Regular follow-up imaging may be necessary to monitor filter position and function.
Frequently Asked Questions
What is the Cordis Multifilar Pervenous Ventric LD used for?
It is used for the placement of inferior vena cava (IVC) filters to prevent pulmonary embolism in high-risk patients.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring protection against 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.