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attain select ii 6248del delivery catheter system
Medtronic, Ireland
Summary: The Attain Select II 6248DEL is a delivery catheter system used primarily for venous stent placement. Key evidence includes its clearance via the FDA 510k pathway and its application in venous-stent clinical scenarios.
FDA Clearance Information
Pathway
510K
Number
K053431 ↗
Decision Date
March 16, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Select II 6248DEL was cleared by the FDA via the 510k pathway on March 16, 2006. Manufactured by Medtronic, Ireland, it is classified as a Class 2 device.
What It Is
The Attain Select II 6248DEL is a delivery catheter system designed for the precise placement of venous stents. It is intended for use in procedures requiring the deployment of stents within the venous system, facilitating improved vascular access.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is employed in scenarios requiring the placement of venous stents to treat conditions such as venous obstructions or insufficiencies.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and prospective analyses. These studies span from 2023 to 2024, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report on the efficacy of the Attain Select II 6248DEL in facilitating successful venous stent placement. The device has been associated with improved procedural outcomes, including enhanced stent deployment accuracy and reduced procedure times.
Safety Profile
Reported complications include device-related malfunctions and procedural complications such as stent misplacement. However, the overall safety profile is consistent with other devices in its class.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device. Further research is needed to assess long-term outcomes and to compare its efficacy with alternative delivery systems.
Frequently Asked Questions
What are the clinical indications for Attain Select II 6248DEL?
The device is indicated for use in the placement of venous stents, particularly in cases of venous obstructions or insufficiencies.
What outcomes have been reported in clinical studies?
Studies report improved stent deployment accuracy and reduced procedure times with the use of the Attain Select II 6248DEL.
What complications have been reported?
Safety data indicate potential complications such as device malfunctions and stent misplacement, though these are consistent with similar devices.
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.