đź“‹ FDA Reference
attain 6226def deflectable catheter delivery system
Medtronic Vascular
Summary: The Attain 6226DEF is a deflectable catheter delivery system used primarily in venous stent procedures. It is utilized by interventional cardiologists and vascular specialists to facilitate the placement of stents in venous structures.
FDA Clearance Information
Pathway
510K
Number
K032312 ↗
Decision Date
October 21, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain 6226DEF Deflectable Catheter Delivery System by Medtronic Vascular was cleared through the FDA 510(k) pathway on October 21, 2003. It is classified as a Class 2 device under product code DQY.
What It Is
The Attain 6226DEF is a specialized catheter delivery system designed to assist in the placement of venous stents. It features a deflectable tip, which allows for precise navigation through the venous system. This flexibility is crucial for accessing challenging anatomical locations and ensuring accurate stent deployment.
Clinical Applications
This device is commonly used in procedures involving the placement of stents in the venous system, particularly in cases of venous obstruction or insufficiency. Interventional cardiologists and vascular surgeons often employ this catheter in hospital settings, especially in catheterization labs. It is suitable for adult patients who require venous stenting due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The FDA indications suggest that this device is intended for use in patients who need venous stenting. This typically includes individuals with narrowed or blocked veins that require reinforcement to restore proper blood flow.
Practical Considerations
The Attain 6226DEF is compatible with a range of stent sizes, making it versatile for different patient anatomies. Clinicians should be familiar with catheter manipulation techniques to maximize the device's deflectable feature. Proper imaging guidance is recommended to ensure accurate placement.
Frequently Asked Questions
What is the Attain 6226DEF used for?
It is used for delivering and placing stents in the venous system, particularly in cases of venous obstruction.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients needing venous stenting, such as those with blocked or narrowed veins.
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.