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cpi model 2215 seamed model 3400
Seamed
Summary: The CPI Model 2215 Seamed Model 3400 is an IVC filter retrieval device used primarily by interventional radiologists to safely remove inferior vena cava filters. It is designed for use in patients who have had temporary IVC filters placed to prevent pulmonary embolism.
FDA Clearance Information
Pathway 510K
Number K910223 ↗
Decision Date March 19, 1991
Product Code DTC
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on March 19, 1991, by Seamed. It is classified as a Class 2 medical device under the product code DTC.
What It Is
The CPI Model 2215 Seamed Model 3400 is a specialized medical device used for the retrieval of inferior vena cava (IVC) filters. These filters are typically placed to prevent blood clots from traveling to the lungs, causing a pulmonary embolism. The device facilitates the safe and effective removal of these filters once they are no longer needed, minimizing the risk of complications associated with long-term filter placement.
Clinical Applications
This device is commonly used in interventional radiology settings for patients who have had temporary IVC filters placed. It is particularly relevant in cases where the risk of deep vein thrombosis or pulmonary embolism has subsided, and the filter is no longer necessary. The device is used in hospitals and specialized clinics, primarily by interventional radiologists and vascular surgeons.
Indications for Use
The FDA indications suggest that this device is intended for the retrieval of IVC filters in patients who have had them placed temporarily. It is used when the risk of blood clots has decreased, and the filter is no longer needed to prevent pulmonary embolism.
Practical Considerations
The device is compatible with standard IVC filters and is typically available in sizes that accommodate various filter types. Clinicians should be familiar with the specific retrieval techniques and ensure compatibility with the filter model used in the patient.
Frequently Asked Questions
What is CPI Model 2215 Seamed Model 3400 used for?
It is used for the retrieval of inferior vena cava (IVC) filters once they are no longer needed.
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 no longer require them 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.