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biotronik dyc unipolar pe-60 4-dyc
Biotronik Sales
Summary: The Biotronik DYC Unipolar PE-60 4-DYC is a medical device used in the management of venous thromboembolism. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K833101 ↗
Decision Date
October 19, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biotronik DYC Unipolar PE-60 4-DYC was cleared through the FDA 510(k) pathway on October 19, 1983. It is manufactured by Biotronik Sales and is classified as a Class III device.
What It Is
The Biotronik DYC Unipolar PE-60 4-DYC is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is implanted in the inferior vena cava, the large vein that carries blood from the lower body to the heart. The device works by providing a mechanical barrier to emboli traveling from the lower extremities, thus reducing the risk of life-threatening pulmonary embolism.
Clinical Applications
This device is commonly used in patients who are at high risk for pulmonary embolism and cannot be managed with anticoagulation therapy alone. It is typically used in interventional radiology suites or operating rooms. The patient population includes those with contraindications to anticoagulation, recurrent embolism despite anticoagulation, or those undergoing high-risk surgical procedures.
Indications for Use
The FDA indications suggest that this device is used for patients at risk of pulmonary embolism who are not candidates for anticoagulation therapy. It is particularly beneficial for those with a history of deep vein thrombosis or those undergoing major surgeries.
Practical Considerations
The Biotronik DYC Unipolar PE-60 4-DYC comes in various sizes to accommodate different patient anatomies. It is important to ensure proper placement and stability within the vena cava. Compatibility with imaging techniques is crucial for accurate placement and follow-up.
Frequently Asked Questions
What is Biotronik DYC Unipolar PE-60 4-DYC 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 be treated with 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.