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attain 6218a-am amplatz guide catheter for left-heart delivery
Medtronic Vascular
Summary: The Attain 6218a-am Amplatz Guide Catheter is a medical device used for left-heart delivery procedures. It is primarily utilized by interventional cardiologists to facilitate the placement of venous stents.
FDA Clearance Information
Pathway
510K
Number
K024035 ↗
Decision Date
December 30, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain 6218a-am Amplatz Guide Catheter was cleared through the FDA 510k pathway on December 30, 2002. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Attain 6218a-am Amplatz Guide Catheter is designed to assist in the delivery of devices to the left side of the heart. It is a flexible, steerable catheter that provides a pathway for other instruments or stents to be placed accurately within the heart's venous system. Its design allows for precise navigation through the vascular system, reducing the risk of complications during procedures.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly in procedures involving the placement of venous stents in the left heart. It is utilized in cardiac catheterization labs and is essential for procedures that require precise delivery of therapeutic devices. The catheter is suitable for adult patients who require interventions to address venous obstructions or other cardiac conditions.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring access to the left side of the heart. It is intended for patients who need interventions such as stent placements to treat conditions affecting the heart's venous system.
Practical Considerations
The Attain 6218a-am Amplatz Guide Catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard guidewires and other interventional tools. Clinicians should be familiar with the catheter's steerability and torque response to optimize procedural outcomes.
Related Literature
The linked study evaluated a new ex-vivo organ model for training in percutaneous renal surgery. It aimed to improve training facilities for this complex procedure by utilizing a porcine kidney model. While the study provided valuable insights into training methodologies, its applicability to human procedures may be limited due to anatomical differences.
Frequently Asked Questions
What is the Attain 6218a-am Amplatz Guide Catheter used for?
It is used for delivering devices to the left side of the heart, particularly in procedures involving venous stents.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring access to the left heart for interventions like stent placements.
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.