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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 ?
510(k)
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.
FDA-Cleared Indications
- Retrieval of temporary inferior vena cava filters.
- Removal of an IVC filter when protection from pulmonary embolism is no longer required.
Clinical Applications
- Image-guided endovascular retrieval of a temporary IVC filter.
- Removal of a retrievable IVC filter after the risk of pulmonary embolism has decreased.
- Use during IVC filter retrieval procedures performed by an interventional radiologist or other qualified vascular specialist.
Practical Considerations
- Compatibility must be confirmed with the specific IVC filter model and the device labeling before use.
- Retrieval is generally performed through venous access under fluoroscopic imaging, with local anesthesia and possible moderate sedation.
- The filter may be difficult or impossible to remove if it has become embedded, tilted, fractured, or incorporated into the caval wall.
- The available sizes, accessories, and handling instructions should be verified from the original manufacturer labeling; this record does not establish current product availability.
- MRI safety cannot be determined from the FDA record provided. The device and any retained filter should be evaluated using current manufacturer MRI labeling before an MRI examination.
Procedures that use this device
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.