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telectronics 030-253 bifurcated
William C. Nealon
Summary: The Telectronics 030-253 Bifurcated is an IVC filter used to prevent pulmonary embolism by capturing blood clots. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K831303 ↗
Decision Date
May 25, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Telectronics 030-253 Bifurcated received FDA clearance through the 510(k) pathway on May 25, 1983. Manufactured by William C. Nealon, it is classified as a Class III device.
What It Is
The Telectronics 030-253 Bifurcated is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing thrombi (blood clots) that travel from the lower extremities. It is deployed via a minimally invasive procedure, typically through a femoral or jugular vein approach. The bifurcated design allows for enhanced stability and clot capture efficiency.
Clinical Applications
This device is commonly used in patients who are at high risk for pulmonary embolism and cannot be managed with anticoagulation therapy. It is frequently utilized in trauma settings, oncology patients with active thrombosis, and those undergoing major surgeries. Interventional radiologists and vascular surgeons typically perform the insertion in a hospital or specialized outpatient setting.
Indications for Use
The FDA indications suggest this device is for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy. It is particularly useful for those with a history of deep vein thrombosis or those undergoing procedures that increase clot risk.
Practical Considerations
The Telectronics 030-253 Bifurcated comes in various sizes to accommodate different patient anatomies. It is compatible with standard delivery systems used in IVC filter placement. Clinicians should be aware of potential complications such as filter migration or vena cava perforation.
Frequently Asked Questions
What is Telectronics 030-253 Bifurcated 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 undergo 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.