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Telectronics Model 2401
Seamed
Summary: The Telectronics Model 2401 is a medical device used for IVC filter retrieval. It is typically utilized by interventional radiologists and vascular surgeons to safely remove inferior vena cava filters from patients.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831697 ↗
Decision Date ?
September 4, 1984
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Telectronics Model 2401 was cleared through the FDA 510(k) pathway on September 4, 1984. Manufactured by Seamed, it is classified as a Class 2 device under product code DTC.
What It Is
The Telectronics Model 2401 is a specialized device designed for the retrieval of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by capturing blood clots. The device facilitates the safe removal of these filters when they are no longer needed or if complications arise. It is engineered to ensure minimal trauma to the vessel during retrieval.
FDA-Cleared Indications
- Retrieval of inferior vena cava filters.
- Removal of an IVC filter in patients for whom filter retrieval is clinically indicated.
Clinical Applications
- Catheter-based retrieval of an IVC filter from the inferior vena cava.
- Removal of a temporary IVC filter after the risk of pulmonary embolism has decreased, when retrieval is indicated.
- Retrieval of an IVC filter when removal is clinically indicated because of a filter-related concern, consistent with the device labeling and filter instructions for use.
Practical Considerations
- Compatibility must be confirmed with the specific IVC filter, retrieval hook or loop, access system, and instructions for use; not every filter can be retrieved with every device.
- The procedure generally requires venous access, fluoroscopic imaging, and sterile catheter-based technique. The access site and retrieval approach depend on the filter and its position.
- The operator should assess filter position, tilt, fracture, penetration, thrombus, and embedment before attempting retrieval. These findings can increase technical difficulty or risk.
- The record provided does not establish MRI safety, device dimensions, or a universal size range. MRI status and sizing should be verified in the current manufacturer documentation before use.
- Potential complications include venous injury, bleeding, filter fracture or embolization, retained filter components, thrombus-related complications, infection, and failure to retrieve the filter.
Procedures that use this device
Frequently Asked Questions
What is Telectronics Model 2401 used for?
It is used for the retrieval of inferior vena cava filters in patients who no longer need them or are experiencing complications.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the retrieval of IVC filters in patients who have had them placed to prevent pulmonary embolism.
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.