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dnr unipolar
Biotronik Sales
Summary: The dnr unipolar is a medical device used in the context of inferior vena cava (IVC) filters. It is primarily utilized by interventional radiologists and vascular surgeons to prevent pulmonary embolism.
FDA Clearance Information
Pathway
510K
Number
K853568 ↗
Decision Date
January 15, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The dnr unipolar, manufactured by Biotronik Sales, received FDA clearance through the 510k pathway on January 15, 1986. It is classified as a Class III device under product code DTB.
What It Is
The dnr unipolar is a type of medical device associated with the use of IVC filters. These filters are designed to capture blood clots that may travel from the lower extremities to the lungs, potentially causing a pulmonary embolism. The device is typically implanted in the inferior vena cava, the large vein that carries deoxygenated blood from the lower body to the heart.
Clinical Applications
The dnr unipolar is commonly used in procedures involving the placement of IVC filters. These procedures are typically performed in hospital settings by interventional radiologists or vascular surgeons. The device is often used in patients who are at high risk for thromboembolic events, such as those with deep vein thrombosis (DVT) or those who cannot take anticoagulant medications.
Indications for Use
The dnr unipolar is indicated for patients who require protection against pulmonary embolism, particularly when anticoagulation therapy is contraindicated or has failed. It is suitable for patients with a history of DVT or those undergoing surgical procedures that increase the risk of clot formation.
Practical Considerations
When using the dnr unipolar, clinicians should consider the size of the IVC and the specific anatomical characteristics of the patient. Compatibility with other vascular devices and the technique for insertion should be reviewed prior to the procedure to ensure optimal outcomes.
Frequently Asked Questions
What is dnr unipolar used for?
The dnr unipolar is used for the prevention of 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 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.