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engage tr introducer
St Jude Medical
Summary: The Engage TR Introducer is a medical device used in vascular procedures to facilitate the insertion of catheters and other devices. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K093130 ↗
Decision Date
November 4, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Engage TR Introducer by St Jude Medical was cleared through the FDA 510(k) pathway on November 4, 2009. It is classified as a Class 2 device under product code DYB.
What It Is
The Engage TR Introducer is a vascular access device designed to aid in the insertion of catheters and other interventional tools into the vascular system. It is typically used in procedures requiring precise access to the vascular system, such as angiography or embolization. The device provides a stable pathway for other instruments, minimizing trauma to the vessel and improving procedural efficiency.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings. It is essential in procedures like embolization, where precise delivery of coils or other embolic materials is required. The Engage TR Introducer is suitable for use in hospitals and specialized clinics, catering to patients requiring vascular interventions, including those with aneurysms or vascular malformations.
Indications for Use
The Engage TR Introducer is indicated for use in patients requiring vascular access for procedures such as embolization. It is designed to facilitate the safe and efficient insertion of interventional devices into the vascular system.
Practical Considerations
The Engage TR Introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and embolization devices, and clinicians should be familiar with the specific technique for insertion to ensure optimal outcomes.
Frequently Asked Questions
What is Engage TR Introducer used for?
The Engage TR Introducer is used to facilitate the insertion of catheters and other devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the Engage TR Introducer during vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as embolization, to aid in the insertion of interventional tools.
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.