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attain command 6250 left heart delivery systems and attain command 6250 guide catheters for left heart delivery
Medtronic
Summary: The Attain Command 6250 is a left heart delivery system used primarily in cardiac procedures to facilitate the placement of leads or catheters. It is typically used by cardiologists in settings such as hospitals and specialized cardiac centers.
FDA Clearance Information
Pathway
510K
Number
K080428 ↗
Decision Date
December 9, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Command 6250 was cleared through the FDA 510(k) pathway on December 9, 2008. It is manufactured by Medtronic and classified as a Class 2 medical device under product code DQY.
What It Is
The Attain Command 6250 is a delivery system designed for the left heart, consisting of guide catheters that assist in the precise placement of medical devices such as leads or catheters within the heart. It is engineered to navigate the complex anatomy of the heart, providing stability and control during cardiac procedures. This device is particularly useful in procedures requiring access to the left side of the heart, such as lead placement for cardiac resynchronization therapy.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving cardiac resynchronization therapy (CRT) where precise placement of leads in the left ventricle is crucial. It is utilized in hospital settings, typically in catheterization labs, by cardiologists and electrophysiologists. The device is suitable for adult patients requiring advanced cardiac interventions, especially those with heart failure or arrhythmias needing CRT.
Indications for Use
The FDA-cleared indications for the Attain Command 6250 involve its use in facilitating the delivery of medical devices to the left side of the heart. It is intended for patients requiring cardiac interventions that involve the placement of leads or catheters in the left heart chambers.
Practical Considerations
The Attain Command 6250 is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard cardiac catheterization equipment and requires careful handling to ensure precise placement. Clinicians should be familiar with catheter navigation techniques to optimize the use of this device.
Frequently Asked Questions
What is the Attain Command 6250 used for?
It is used for delivering medical devices to the left side of the heart, particularly in procedures like cardiac resynchronization therapy.
What specialties typically use this device?
Interventional cardiologists and electrophysiologists primarily use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the delivery of leads or catheters to the left heart chambers in cardiac 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.