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Model 4810 Analyzer Output Adapter
Pace Medical
Summary: The Model 4810 Analyzer Output Adapter by Pace Medical is a specialized device used in the retrieval of inferior vena cava (IVC) filters. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K002497 ↗
Decision Date ?
October 10, 2000
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Model 4810 Analyzer Output Adapter was cleared via the FDA 510(k) pathway on October 10, 2000. It is manufactured by Pace Medical and classified as a Class 2 device under product code DTC.
What It Is
The Model 4810 Analyzer Output Adapter is a medical device designed to interface with analyzers used during the retrieval of IVC filters. It facilitates the accurate and efficient extraction of these filters, which are used to prevent pulmonary embolism in patients with deep vein thrombosis. The device ensures compatibility with various analyzer systems, enhancing procedural outcomes.
FDA-Cleared Indications
- Use as an analyzer output adapter during retrieval of inferior vena cava filters.
Clinical Applications
- Supporting an IVC filter retrieval procedure in interventional radiology.
- Connecting or interfacing compatible analyzer equipment used during IVC filter retrieval.
- Assisting retrieval of an IVC filter after the risk of pulmonary embolism has decreased, when removal is clinically indicated.
Practical Considerations
- Confirm compatibility with the analyzer and other equipment used at the treating facility before the procedure.
- The adapter is an accessory and does not independently remove an IVC filter; retrieval is performed with appropriate endovascular tools and imaging guidance.
- The available FDA record does not specify MRI safety, dimensions, or a complete size range. Obtain current manufacturer labeling before use in an MRI environment or with a specific analyzer.
- Use should follow the device instructions for use and the operator's established IVC filter retrieval technique.
- Patient-specific contraindications and risks relate primarily to the IVC filter retrieval procedure, including access-site bleeding, venous injury, filter fracture or migration, and thromboembolic complications.
Procedures that use this device
Frequently Asked Questions
What is the Model 4810 Analyzer Output Adapter used for?
It is used for the retrieval of inferior vena cava (IVC) filters in patients who no longer require them.
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 use in the retrieval of IVC filters, particularly in patients who had these filters 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.