📋 FDA Reference
Attain Lds 6216 Left-Heart Delivery System
Medtronic Vascular
Summary: The Attain LDS 6216 is a left-heart delivery system used for placing leads in the left side of the heart. It is primarily used by cardiologists during cardiac resynchronization therapy (CRT) procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K012130 ↗
Decision Date ?
August 28, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Attain LDS 6216 was cleared through the FDA 510(k) pathway on August 28, 2001. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain LDS 6216 is a delivery system designed for the precise placement of cardiac leads in the left side of the heart. It consists of a catheter system that facilitates the navigation through the venous system to the heart. This device is crucial in procedures requiring the placement of pacing leads for cardiac resynchronization therapy, which helps manage heart failure by coordinating the heart's contractions.
FDA-Cleared Indications
- Used as a percutaneous catheter delivery system for positioning cardiac leads in the left-heart circulation.
- Used to facilitate lead placement during cardiac resynchronization therapy procedures.
Clinical Applications
- Delivery and positioning of a cardiac pacing lead during cardiac resynchronization therapy.
- Catheter navigation through the venous system to access the coronary sinus and its branches for left-ventricular lead placement.
- Use in hospital electrophysiology or cardiac catheterization laboratories by clinicians trained in cardiac lead implantation.
Practical Considerations
- The device is intended for use by clinicians familiar with venous access, coronary sinus anatomy and cardiac lead-placement techniques.
- Access and navigation generally involve the venous system, commonly through an upper-extremity or chest venous approach, with fluoroscopic imaging.
- Compatibility should be confirmed with the intended cardiac lead, guidewire and other delivery-system components before use.
- The FDA record identifies the device as a Class II percutaneous catheter under product code DQY; the available information does not establish MRI safety or conditional labeling.
- Contraindications, warnings, dimensions and detailed compatibility information should be taken from the current manufacturer instructions for use.
Frequently Asked Questions
What is the Attain LDS 6216 used for?
The Attain LDS 6216 is used for placing cardiac leads in the left side of the heart during cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and heart failure management, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in cardiac resynchronization therapy, specifically for placing leads in the left side of the heart for patients 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.