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6f engage engage tr introducer
St Jude Medical
Summary: The 6F Engage TR Introducer is a medical device used to facilitate the insertion of catheters and other devices into the vascular system, primarily by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K101883 ↗
Decision Date
September 7, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 6F Engage TR Introducer by St Jude Medical was cleared through the FDA 510(k) pathway on September 7, 2010. It is a Class 2 device under product code DYB.
What It Is
The 6F Engage TR Introducer is a sheath device designed to provide access to the vascular system, allowing for the insertion of catheters and other interventional devices. It is typically used in procedures requiring vascular access, such as angiography or embolization. The device features a hemostatic valve to minimize blood loss during procedures.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings for procedures like angioplasty, stent placement, and embolization. It is suitable for use in hospitals and specialized clinics, serving adult patients who require vascular interventions. The introducer is particularly valuable in procedures involving the femoral or radial arteries.
Indications for Use
The FDA indications for the 6F Engage TR Introducer include its use in facilitating the introduction of catheters and other devices into the vascular system. It is indicated for patients undergoing procedures that require vascular access, such as those with cardiovascular conditions.
Practical Considerations
The 6F Engage TR Introducer is compatible with a range of catheter sizes and is designed for ease of insertion and removal. Clinicians should be familiar with vascular access techniques and consider patient-specific factors such as vessel size and condition when selecting this device.
Frequently Asked Questions
What is the 6F Engage TR Introducer used for?
It 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 cardiologists and radiologists commonly use this device in procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of catheters and other devices into the vascular system for patients undergoing vascular access procedures.
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.