đź“‹ FDA Reference
attain command surevalve left heart delivery system attain command guide catheters for left heart delivery attain select
Medtronic, Ireland
Summary: The Attain Command SureValve is a left heart delivery system used primarily for the placement of venous stents. It is utilized by cardiologists and interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K123153 ↗
Decision Date
April 9, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Command SureValve received FDA clearance via the 510(k) pathway on April 9, 2013. Manufactured by Medtronic in Ireland, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain Command SureValve is a specialized catheter system designed for the delivery of devices to the left side of the heart. It facilitates precise placement of venous stents and other therapeutic devices. The system includes guide catheters that provide stability and control during procedures, ensuring accurate device deployment.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures involving the left heart, such as the placement of venous stents in patients with heart failure or other cardiac conditions. It is typically used in hospital catheterization labs by specialists trained in endovascular techniques. The device is suitable for adult patients requiring left heart interventions.
Indications for Use
The Attain Command SureValve is indicated for use in patients requiring the delivery of therapeutic devices to the left heart. This includes individuals with conditions that necessitate venous stenting, such as certain types of heart failure or structural heart disease.
Practical Considerations
The system is compatible with a range of stent sizes and is designed for use with standard interventional techniques. Clinicians should be familiar with catheter navigation and manipulation within the left heart to ensure optimal outcomes. Proper imaging guidance is recommended during use.
Frequently Asked Questions
What is the Attain Command SureValve used for?
It is used for the delivery of venous stents and other therapeutic devices to the left heart.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for delivering devices to the left heart in patients needing venous stenting, such as those with heart failure.
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.