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attain lds 6216a left-heart delivery system model 6216a
Medtronic Vascular
Summary: The Attain LDS 6216A is a left-heart delivery system used for the placement of venous stents. It is primarily utilized by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K021587 ↗
Decision Date
May 30, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain LDS 6216A was cleared through the FDA 510(k) pathway on May 30, 2002. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain LDS 6216A is a medical device designed to facilitate the delivery of stents to the left side of the heart. It consists of a catheter system that provides access to the heart's venous system, allowing for precise placement of stents. This device is crucial in procedures where maintaining patency of the venous pathways is necessary.
Clinical Applications
This device is commonly used in interventional cardiology and vascular surgery settings, particularly in procedures involving the placement of stents in the heart's venous system. It is suitable for patients with conditions that require venous stenting to improve blood flow or relieve blockages. The device is typically used in hospitals and specialized cardiac centers.
Indications for Use
The FDA indications for the Attain LDS 6216A involve its use in delivering stents to the left heart's venous system. It is intended for patients who need venous stenting due to conditions like venous insufficiency or blockages.
Practical Considerations
The Attain LDS 6216A is compatible with a range of stent sizes, making it versatile for different patient anatomies. Clinicians should be familiar with catheterization techniques and ensure proper imaging guidance during the procedure for optimal results.
Frequently Asked Questions
What is the Attain LDS 6216A used for?
It is used for delivering stents to the left heart's venous system to treat conditions like venous blockages.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for delivering venous stents to the left heart, particularly in cases of venous insufficiency or blockages.
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.