đź“‹ FDA Reference

attain 6227def deflectable catheter delivery system

Medtronic, Ireland

Summary: The Attain 6227DEF is a deflectable catheter delivery system used in venous stent procedures. It is primarily utilized by interventional cardiologists and electrophysiologists.

FDA Clearance Information

Pathway 510K
Decision Date August 21, 2006
Product Code DQY
Device Class Class 2
Evidence 0 studies

The Attain 6227DEF was cleared through the FDA 510(k) pathway on August 21, 2006. Manufactured by Medtronic, Ireland, it is classified as a Class 2 device under product code DQY.

What It Is

The Attain 6227DEF is a deflectable catheter delivery system designed to facilitate the placement of venous stents. It features a steerable tip that allows for precise navigation through the venous system, enhancing access to challenging anatomical sites. This device is particularly useful in procedures requiring precise stent placement in the cardiac venous system.

Clinical Applications

Commonly used in interventional cardiology and electrophysiology, the Attain 6227DEF is employed in procedures involving the placement of stents within the cardiac veins. It is often used in patients with heart failure requiring cardiac resynchronization therapy (CRT) where precise stent placement is critical. The device is typically used in hospital settings, including catheterization labs.

Indications for Use

The Attain 6227DEF is indicated for use in patients requiring venous stenting, particularly in the context of cardiac resynchronization therapy. It is suitable for patients with heart failure who need improved cardiac function through optimized stent placement.

Practical Considerations

The Attain 6227DEF is compatible with a range of stent sizes and is designed for use with standard guidewires. Clinicians should be familiar with catheter manipulation techniques to maximize the device's deflectable capabilities. Proper imaging techniques are recommended to ensure accurate placement.

Frequently Asked Questions

What is the Attain 6227DEF used for?

The Attain 6227DEF is used for the delivery and placement of venous stents, particularly in cardiac resynchronization therapy procedures.

What specialties typically use this device?

Interventional cardiologists and electrophysiologists typically use the Attain 6227DEF in cardiac procedures.

What are the FDA-cleared indications?

The device is indicated for venous stenting in patients undergoing cardiac resynchronization therapy, especially those with heart failure.

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.

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