📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For use with compatible IVC filter systems during placement in the inferior vena cava.
- For facilitating attachment or deployment of an IVC filter in patients for whom an IVC filter is indicated to reduce the risk of pulmonary embolism from venous thrombi.
Clinical Applications
- Accessory use during percutaneous IVC filter placement.
- Connection of a compatible IVC filter to its delivery or deployment system.
- Assistance with positioning and deployment of a compatible IVC filter in the inferior vena cava.
- Use in interventional radiology or vascular surgery procedures when the compatible filter system requires the adapter.
Practical Considerations
- Compatibility must be confirmed with the specific IVC filter, delivery catheter, and deployment system before the procedure.
- Use should follow the device and compatible filter system instructions for use, including assembly, handling, and deployment steps.
- The adapter is an accessory rather than a standalone IVC filter; it does not independently prevent pulmonary embolism.
- MRI safety information is not established by the available FDA record. Do not assume the adapter or the connected filter system is MR safe or MR conditional without current manufacturer labeling.
- Potential complications are primarily related to the associated IVC filter procedure and may include bleeding, vascular injury, malposition, filter migration, thrombosis, or difficulty with retrieval when retrieval is indicated.
Procedures that use this device
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.