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ultimum engage engage tr
St Jude Medical
Summary: The Ultimum Engage Engage TR is an embolization coil used primarily in interventional radiology to occlude blood vessels. It is utilized by specialists to treat conditions such as aneurysms or to control bleeding.
FDA Clearance Information
Pathway
510K
Number
K091137 ↗
Decision Date
April 22, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Ultimum Engage Engage TR received FDA clearance through the 510(k) pathway on April 22, 2009. Manufactured by St Jude Medical, it is classified as a Class II device under product code DYB.
What It Is
The Ultimum Engage Engage TR is a medical device designed for embolization procedures, where it is used to occlude or block blood vessels. This device consists of coils that are deployed into the vascular system to prevent blood flow to specific areas, which can be critical in managing conditions like aneurysms or in controlling hemorrhages. Its design allows for precise placement and controlled deployment, making it a valuable tool in interventional radiology.
Clinical Applications
Clinically, the Ultimum Engage Engage TR is used in interventional radiology and vascular surgery settings. It is commonly employed in procedures to treat cerebral and peripheral aneurysms, as well as to manage gastrointestinal bleeding or trauma-related hemorrhages. The device is typically used in hospital settings, particularly in catheterization labs or operating rooms, and is suitable for a wide range of patient populations requiring vascular occlusion.
Indications for Use
The device is indicated for use in patients who require embolization to treat conditions such as aneurysms or to control bleeding. It is suitable for occluding blood vessels in various parts of the body, depending on the clinical need.
Practical Considerations
The Ultimum Engage Engage TR comes in various sizes to accommodate different vessel diameters and anatomical locations. It is compatible with standard catheter systems used in embolization procedures. Clinicians should be trained in endovascular techniques to ensure proper deployment and positioning of the coils.
Frequently Asked Questions
What is Ultimum Engage Engage TR used for?
It is used for embolization to occlude blood vessels, treating conditions like aneurysms or controlling bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for embolization to treat aneurysms and control bleeding by occluding blood vessels.
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.