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attain lds 6216a left heart delivery system attain access 6218a left heart delivery system attain 6216a and 6218a guid
Medtronic
Summary: The Attain LDS 6216A and 6218A are left heart delivery systems used in cardiac procedures to facilitate the placement of leads in the left heart. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway 510K
Number K112917 ↗
Decision Date October 27, 2011
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Attain LDS 6216A and 6218A were cleared through the FDA 510(k) pathway on October 27, 2011. Manufactured by Medtronic, these devices are classified as Class 2 under product code DQY.
What It Is
The Attain LDS 6216A and 6218A are specialized delivery systems designed to assist in the placement of cardiac leads within the left side of the heart. These systems provide a pathway through the venous system to reach the target site, ensuring precise lead placement. The devices are essential in procedures requiring accurate navigation and positioning in the heart's complex anatomy.
Clinical Applications
These delivery systems are commonly used in electrophysiology labs and cardiac catheterization settings. They are crucial in procedures involving the implantation of cardiac resynchronization therapy (CRT) devices, particularly in patients with heart failure who require precise lead placement for optimal therapy. Cardiologists and electrophysiologists use these systems to ensure effective treatment outcomes.
Indications for Use
The FDA indications for the Attain LDS 6216A and 6218A involve providing a means to deliver cardiac leads to the left heart. These devices are used in patients needing cardiac resynchronization therapy, often due to heart failure or other cardiac conditions requiring lead placement.
Practical Considerations
The Attain LDS systems are compatible with various lead sizes and are designed for ease of navigation through the venous system. Clinicians should be familiar with the technique for accessing the coronary sinus and navigating the venous anatomy to ensure successful lead placement.
Frequently Asked Questions
What is the Attain LDS 6216A & 6218A used for?
These devices are used to facilitate the placement of cardiac leads in the left heart, primarily for cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in cardiac procedures.
What are the FDA-cleared indications?
The devices are indicated for use in delivering cardiac leads to the left heart, particularly in patients requiring 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.