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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 510K
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients requiring the retrieval of IVC filters. These filters are typically placed in patients at risk of pulmonary embolism due to deep vein thrombosis. The Model 4810 Adapter aids in the safe and effective removal of these filters once the risk has subsided.
Indications for Use
The FDA-cleared indication for the Model 4810 Analyzer Output Adapter is its use in the retrieval of IVC filters. This is relevant for patients who have had these filters placed to prevent blood clots from traveling to the lungs and who now require their removal.
Practical Considerations
Clinicians should ensure compatibility of the Model 4810 Adapter with their existing analyzer systems. Proper technique during the retrieval process is crucial to avoid complications. The device is typically available in standard sizes to fit most procedural requirements.
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.