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biotronik i-unipolar pe-60 2-13
Biotronik Sales
Summary: The Biotronik I-Unipolar PE-60 2-13 is a medical device used in the placement of inferior vena cava (IVC) filters. It is primarily utilized by interventional radiologists and vascular surgeons to prevent pulmonary embolism in patients at risk.
FDA Clearance Information
Pathway
510K
Number
K833108 ↗
Decision Date
October 19, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik I-Unipolar PE-60 2-13 was cleared through the FDA 510(k) pathway on October 19, 1983. It is manufactured by Biotronik Sales and classified as a Class III device.
What It Is
The Biotronik I-Unipolar PE-60 2-13 is a medical device designed for the placement of inferior vena cava (IVC) filters. These filters are used to prevent blood clots from traveling to the lungs, which can cause a pulmonary embolism. The device aids in the precise placement of the filter within the IVC, ensuring optimal positioning and effectiveness.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in patients who are at high risk for venous thromboembolism and cannot be managed with anticoagulation therapy alone. The device is typically used in hospitals or specialized clinics where vascular procedures are performed.
Indications for Use
The FDA indications for this device involve the prevention of pulmonary embolism in patients with a history of deep vein thrombosis or other conditions that predispose them to blood clots. It is particularly indicated for patients who are not candidates for anticoagulation therapy.
Practical Considerations
The Biotronik I-Unipolar PE-60 2-13 is compatible with standard IVC filter systems. Clinicians should be familiar with the sizing and positioning techniques to ensure proper deployment. It is important to follow the manufacturer's guidelines for use to avoid complications.
Frequently Asked Questions
What is Biotronik I-Unipolar PE-60 2-13 used for?
It is used for the placement of IVC filters to prevent pulmonary embolism in at-risk patients.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for preventing pulmonary embolism in patients at risk due to conditions like deep vein thrombosis, 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.