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permanthane 866 bipolar coaxial
Pacesetter Systems
Summary: The Permanthane 866 Bipolar Coaxial is a medical device used primarily in interventional cardiology for procedures involving IVC filters. It is utilized by cardiologists and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K832987 ↗
Decision Date
October 20, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Permanthane 866 Bipolar Coaxial was cleared through the FDA 510(k) pathway on October 20, 1983, by Pacesetter Systems. It is classified as a Class III device under product code DTB.
What It Is
The Permanthane 866 Bipolar Coaxial is a specialized medical device designed for use in procedures involving inferior vena cava (IVC) filters. It features a bipolar coaxial design, which aids in precise placement and stability of the filter within the vena cava. This device is crucial in preventing pulmonary embolism by capturing blood clots before they reach the lungs.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for the placement of IVC filters in patients at risk of pulmonary embolism. It is typically used in hospital settings, particularly in catheterization labs or interventional radiology suites. The patient population includes those with deep vein thrombosis or those who cannot tolerate anticoagulation therapy.
Indications for Use
The FDA indications for the Permanthane 866 Bipolar Coaxial involve its use in patients who require the placement of an IVC filter to prevent pulmonary embolism. This is particularly relevant for patients with a history of venous thromboembolism.
Practical Considerations
Clinicians should be aware of the device's compatibility with various IVC filter models and ensure proper sizing for individual patient anatomy. Familiarity with the coaxial technique is essential for successful deployment and positioning of the filter.
Frequently Asked Questions
What is Permanthane 866 Bipolar Coaxial used for?
It is used for the placement of inferior vena cava (IVC) filters to prevent pulmonary embolism.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring IVC filter placement to prevent pulmonary embolism, especially those with venous thromboembolism.
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.