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attain access 6218a left-heart delivery system model 6218
Medtronic Vascular
Summary: The Attain Access 6218A is a left-heart delivery system used primarily in cardiac procedures to facilitate the placement of venous stents. It is typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K021589 ↗
Decision Date
May 30, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Access 6218A was cleared through the FDA 510k pathway on May 30, 2002, by Medtronic Vascular. It is classified as a Class 2 device under product code DQY.
What It Is
The Attain Access 6218A Left-Heart Delivery System is a medical device designed to assist in the delivery and placement of venous stents within the heart. It comprises a catheter system that provides access to the left side of the heart via the venous system. This device is crucial in procedures requiring precise stent placement to ensure optimal blood flow and reduce complications associated with cardiac interventions.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly for patients requiring stent placement in the left heart. It is utilized in procedures to treat conditions such as coronary artery disease or heart failure where venous stenting is indicated. The device is suitable for use in hospital catheterization labs and specialized cardiac centers, catering to adult patients with complex cardiac conditions.
Indications for Use
The FDA indications for the Attain Access 6218A involve its use in facilitating the placement of venous stents in the left heart. It is intended for patients with conditions that necessitate improved venous access and stenting, such as those with obstructive coronary artery disease.
Practical Considerations
The Attain Access 6218A is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard stenting equipment and requires familiarity with catheter-based techniques. Clinicians should ensure proper sizing and positioning to optimize outcomes and reduce procedural risks.
Frequently Asked Questions
What is the Attain Access 6218A used for?
The Attain Access 6218A is used for delivering and placing venous stents in the left heart during cardiac procedures.
What specialties typically use this device?
Cardiologists and interventional radiologists typically use this device in cardiac catheterization and stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients with conditions requiring improved venous access in the left heart.
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.