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engage engage tr introducers
St Jude Medical
Summary: The Engage TR Introducers by St Jude Medical are medical devices used primarily in interventional radiology and cardiology for the introduction of embolization coils. They are typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K111092 ↗
Decision Date
June 9, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Engage TR Introducers were cleared through the FDA 510(k) pathway on June 9, 2011. Manufactured by St Jude Medical, this device is classified as Class 2 under product code DYB.
What It Is
The Engage TR Introducers are specialized medical devices designed to facilitate the introduction of embolization coils into the vascular system. They are typically used during minimally invasive procedures to treat conditions such as aneurysms or to control bleeding. The device ensures precise placement of coils, which are used to block blood flow to specific areas.
Clinical Applications
These introducers are commonly used in interventional radiology and cardiology, particularly in procedures involving embolization. They are essential in treating patients with vascular abnormalities, such as aneurysms, or in cases where controlling internal bleeding is necessary. The device is often used in hospital settings, particularly in catheterization labs or interventional suites.
Indications for Use
The Engage TR Introducers are indicated for use in patients requiring embolization procedures. This typically includes individuals with aneurysms or those needing vascular occlusion to manage bleeding or other vascular conditions.
Practical Considerations
The Engage TR Introducers come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard embolization coils and require careful handling to ensure precise placement. Clinicians should be familiar with catheterization techniques when using this device.
Frequently Asked Questions
What is Engage TR Introducers used for?
The device is used for the introduction of embolization coils during procedures to treat aneurysms or control bleeding.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures, typically for treating aneurysms or managing bleeding.
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.