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acs enhanced-torque coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The ACS Enhanced-Torque Coronary Guiding Catheter is a device used in interventional cardiology to provide support and guidance for other instruments during coronary procedures. It is primarily used by cardiologists in catheterization labs.
FDA Clearance Information
Pathway
510K
Number
K871425 ↗
Decision Date
May 22, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Enhanced-Torque Coronary Guiding Catheter was cleared through the FDA's 510(k) pathway on May 22, 1987. It is manufactured by Advanced Cardiovascular Systems and is classified as a Class 2 device.
What It Is
The ACS Enhanced-Torque Coronary Guiding Catheter is a specialized catheter designed to facilitate the delivery of interventional devices to the coronary arteries. It features enhanced torque control, allowing for precise navigation through the vascular system. This device is crucial in procedures such as angioplasty, where stable access to the coronary arteries is required.
Clinical Applications
This catheter is commonly used in percutaneous coronary interventions (PCI), particularly in settings like cardiac catheterization labs. It is essential for cardiologists performing procedures such as balloon angioplasty or stent placement in patients with coronary artery disease. The catheter's design allows for improved maneuverability and support, making it suitable for complex coronary anatomies.
Indications for Use
The device is indicated for use in patients requiring coronary interventions, such as those with blocked or narrowed coronary arteries. It is used to guide and support the delivery of therapeutic devices to the site of a coronary lesion.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional equipment and requires careful handling to maintain its torque control properties. Clinicians should be familiar with its use in conjunction with other coronary intervention tools.
Frequently Asked Questions
What is the ACS Enhanced-Torque Coronary Guiding Catheter used for?
It is used to provide support and guidance for interventional devices during coronary procedures such as angioplasty.
What specialties typically use this device?
This device is primarily used by interventional cardiologists in catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in guiding and supporting the delivery of therapeutic devices to the coronary arteries during interventions.
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.