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siemens elema models 4025 and 4026 adapters
Pacesetter Systems
Summary: The Siemens Elema Models 4025 and 4026 Adapters are medical devices used in conjunction with IVC filters. They are primarily used by interventional radiologists and vascular surgeons to assist in the placement and retrieval of these filters.
FDA Clearance Information
Pathway
510K
Number
K890547 ↗
Decision Date
March 22, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Siemens Elema Models 4025 and 4026 Adapters were cleared through the FDA 510(k) pathway on March 22, 1989. Manufactured by Pacesetter Systems, these devices are classified as Class III under product code DTB.
What It Is
The Siemens Elema Models 4025 and 4026 Adapters are specialized medical devices designed to work with inferior vena cava (IVC) filters. These adapters facilitate the secure attachment and deployment of IVC filters, which are used to prevent pulmonary embolism by capturing blood clots. The adapters are essential for ensuring the correct positioning and stability of the filters within the vena cava.
Clinical Applications
These adapters are commonly used in interventional radiology and vascular surgery settings. They are crucial during procedures involving the placement or retrieval of IVC filters, especially in patients at risk for venous thromboembolism. The devices are typically used in hospital settings, where precise and reliable deployment of IVC filters is necessary for patient safety.
Indications for Use
The FDA indications suggest that these adapters are intended for use in patients requiring IVC filters, particularly those at high risk for blood clots traveling to the lungs. They are used to ensure the proper placement and function of the filters.
Practical Considerations
Clinicians should be aware of the compatibility of these adapters with specific IVC filter models. Proper technique is essential for ensuring the secure attachment and deployment of the filters. Familiarity with the device's operation can enhance procedural efficiency and patient outcomes.
Frequently Asked Questions
What is Siemens Elema Models 4025 and 4026 Adapters used for?
These adapters are used to facilitate the placement and retrieval of IVC filters, which help prevent pulmonary embolism by capturing blood clots.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use these devices in hospital settings.
What are the FDA-cleared indications?
The adapters are indicated for use in patients requiring IVC filters to prevent blood clots from reaching the lungs.
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.