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biotronik dfh unipolar pe-60 4-dfh
Biotronik Sales
Summary: The Biotronik DFH Unipolar PE-60 4-DFH is an inferior vena cava (IVC) filter used to prevent pulmonary embolism in patients at risk of blood clots. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K833106 ↗
Decision Date
October 20, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik DFH Unipolar PE-60 4-DFH was cleared via the FDA 510k pathway on October 20, 1983. Manufactured by Biotronik Sales, it is classified as a Class III medical device.
What It Is
The Biotronik DFH Unipolar PE-60 4-DFH is a medical device designed as an inferior vena cava filter. It is implanted into the inferior vena cava to capture and prevent large blood clots from traveling to the lungs, thereby reducing the risk of pulmonary embolism. The device is unipolar, indicating a specific configuration that may affect its placement and function.
Clinical Applications
This device is commonly used in patients who are at high risk of developing venous thromboembolism but cannot be managed with anticoagulation therapy alone. It is typically inserted in a hospital setting by interventional radiologists or vascular surgeons. Patients with contraindications to anticoagulation or those who have experienced recurrent embolism despite anticoagulation are typical candidates.
Indications for Use
The Biotronik DFH Unipolar PE-60 4-DFH is indicated for use in patients who are at risk of pulmonary embolism due to blood clots. It is particularly useful for those who cannot take blood thinners or have had recurrent clots despite medication.
Practical Considerations
When considering the use of this IVC filter, clinicians should be aware of the typical sizing and ensure compatibility with the patient's anatomy. Proper imaging and technique during insertion are crucial for optimal placement and function.
Frequently Asked Questions
What is Biotronik DFH Unipolar PE-60 4-DFH used for?
It is used to prevent 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?
It is indicated for patients at risk of pulmonary embolism who cannot use anticoagulation therapy.
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.