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elc 35-up model number 116015 and elc 54-up model number 115606
Biotronik
Summary: The elc 35-up and 54-up by Biotronik are medical devices used as inferior vena cava (IVC) filters. They are primarily used by interventional radiologists and vascular surgeons to prevent pulmonary embolism in patients at risk.
FDA Clearance Information
Pathway
510K
Number
K965106 ↗
Decision Date
January 27, 1998
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The elc 35-up and 54-up were cleared via the FDA 510(k) pathway on January 27, 1998. Manufactured by Biotronik, these devices are classified as Class III under product code DTB.
What It Is
The elc 35-up and 54-up are inferior vena cava (IVC) filters designed to prevent pulmonary embolism by capturing blood clots before they reach the lungs. These devices are inserted into the IVC, a large vein that carries blood from the lower body to the heart. They work by providing a mechanical barrier to emboli while allowing normal blood flow.
Clinical Applications
These IVC filters are commonly used in patients who have a high risk of developing pulmonary embolism but cannot be managed with anticoagulation therapy. They are often employed in settings such as trauma centers, surgical units, and interventional radiology suites. Typical patient populations include those with deep vein thrombosis (DVT), recent surgery, or trauma.
Indications for Use
The FDA indications for these devices include prevention of recurrent pulmonary embolism in patients with contraindications to anticoagulation therapy. They are suitable for individuals at high risk of thromboembolic events.
Practical Considerations
These devices come in various sizes to accommodate different patient anatomies. Compatibility with imaging techniques such as fluoroscopy is essential for accurate placement. Clinicians should be aware of potential complications like filter migration or thrombosis.
Frequently Asked Questions
What is elc 35-up & 54-up used for?
These devices are used as IVC filters to prevent pulmonary embolism in patients who cannot take anticoagulants.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use these devices.
What are the FDA-cleared indications?
These devices are indicated for preventing recurrent pulmonary embolism in patients with contraindications to 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.