đź“‹ FDA Reference
attain command 6250 left heart delivery systems and guide catheters for left heart delivery
Medtronic
Summary: The Attain Command 6250 is a left heart delivery system and guide catheter used primarily in cardiac procedures. It is utilized by cardiologists for precise catheter placement in the left heart.
FDA Clearance Information
Pathway
510K
Number
K090659 ↗
Decision Date
March 26, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Command 6250 was cleared via the FDA 510(k) pathway on March 26, 2009. Manufactured by Medtronic, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain Command 6250 is a delivery system and guide catheter designed for accessing the left side of the heart. It facilitates the placement of various devices such as pacemaker leads or stents within the heart's left chambers. The catheter's design allows for flexibility and precision, making it a valuable tool in interventional cardiology.
Clinical Applications
This device is commonly used in interventional cardiology procedures, particularly in the placement of cardiac resynchronization therapy (CRT) devices. It is employed in catheterization labs by cardiologists to navigate the complex anatomy of the left heart. Patients with heart failure or arrhythmias who require device implantation are typical candidates.
Indications for Use
The Attain Command 6250 is indicated for use in procedures requiring access to the left heart, such as the placement of pacemaker leads or stents. It is suitable for patients needing cardiac resynchronization therapy or other left heart interventions.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional cardiology equipment. Clinicians should be familiar with catheter navigation techniques to optimize its use.
Frequently Asked Questions
What is Attain Command 6250 used for?
It is used for accessing the left heart to place devices like pacemaker leads or stents.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
It is indicated for procedures requiring access to the left heart, such as device implantation for cardiac resynchronization therapy.
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.