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attain access 6218 left-heart delivery system model 6218
Medtronic Vascular
Summary: The Attain Access 6218 is a left-heart delivery system used primarily in cardiac procedures to facilitate access to the left side of the heart. It is typically used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K012083 ↗
Decision Date
August 28, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Access 6218 was cleared through the FDA 510k 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 Access 6218 is a specialized delivery system designed to provide access to the left side of the heart. It is used in procedures requiring precise navigation through the venous system to reach the heart. The system is designed to be compatible with various catheters and guidewires, facilitating the delivery of therapeutic devices or diagnostic tools.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures such as cardiac resynchronization therapy (CRT) where access to the left ventricle is necessary. It is used in hospital settings, typically in catheterization labs, and is suitable for patients requiring interventions on the left side of the heart. The device is essential for procedures involving the placement of leads or other devices in the heart.
Indications for Use
The Attain Access 6218 is indicated for use in patients who require access to the left side of the heart for diagnostic or therapeutic procedures. It is particularly useful in cases where precise navigation through the venous system is necessary.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires, allowing for flexibility in procedural planning. Clinicians should be familiar with the device's handling and navigation techniques to optimize outcomes.
Frequently Asked Questions
What is the Attain Access 6218 used for?
It is used to provide access to the left side of the heart for diagnostic or therapeutic procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for use in accessing the left side of the heart for various 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.