đź“‹ FDA Reference
Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery
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 ?
510(k)
Number ?
K080428 ↗
Decision Date ?
December 9, 2008
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Facilitates percutaneous delivery of medical devices to the left side of the heart.
- Provides guide-catheter support for positioning compatible leads or catheters during left-heart procedures.
Clinical Applications
- Percutaneous delivery of compatible cardiac leads or catheters to the left side of the heart.
- Guide-catheter support during procedures requiring controlled access to the left-heart chambers or coronary venous anatomy.
- Use in hospital catheterization or electrophysiology laboratories by trained cardiac clinicians.
Practical Considerations
- Available configurations and sizes should be selected according to the target anatomy, access route and compatible lead or catheter.
- Use requires fluoroscopic or other appropriate imaging guidance and trained catheter-navigation technique.
- The operator should confirm compatibility with the intended lead, catheter, introducer and other procedural equipment before use.
- The device is intended for single-use catheter-based procedures; it should not be reused or resterilized unless the current manufacturer labeling specifically permits it.
- MRI safety depends on the complete implanted system and any lead or device ultimately delivered; the catheter itself should be assessed using the current Medtronic labeling before MRI exposure.
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.