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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 510K
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.
Clinical Applications
This device is primarily used in interventional radiology and vascular surgery settings. It is employed in procedures involving patients who have had IVC filters placed temporarily, such as those recovering from surgery or trauma. The device is crucial in scenarios where the filter needs to be removed to prevent long-term complications or when the risk of embolism has subsided.
Indications for Use
The FDA indications for the Telectronics Model 2401 involve the retrieval of IVC filters. It is indicated for use in patients who have had these filters placed to prevent pulmonary embolism and now require their removal due to clinical reasons.
Practical Considerations
Clinicians should be aware of the typical sizing and compatibility of the device with various filter types. Proper technique is essential to minimize vessel trauma during retrieval. Familiarity with the device's operation and potential complications is important for successful outcomes.
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.