đź“‹ FDA Reference
acs et hi-flow enhanced torque coronary guid cath
Advanced Cardiovascular Systems
Summary: The ACS ET Hi-Flow Enhanced Torque Coronary Guiding Catheter is a medical device used to facilitate the delivery of interventional devices to the coronary arteries. It is primarily used by interventional cardiologists during procedures such as angioplasty or stent placement.
FDA Clearance Information
Pathway
510K
Number
K926421 ↗
Decision Date
March 23, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS ET Hi-Flow Enhanced Torque Coronary Guiding Catheter was cleared by the FDA via the 510(k) pathway on March 23, 1993. It is manufactured by Advanced Cardiovascular Systems and classified as a Class II medical device.
What It Is
The ACS ET Hi-Flow Enhanced Torque Coronary Guiding Catheter is designed to provide support and guidance for interventional devices during coronary procedures. It features enhanced torque control and high-flow capabilities, which help in navigating the complex coronary anatomy. The catheter is inserted through the femoral or radial artery and advanced to the coronary arteries, where it serves as a conduit for other devices.
Clinical Applications
This device is commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCI) such as angioplasty or stent placement. It is utilized in hospital catheterization labs by cardiologists to treat patients with coronary artery disease. The catheter's design allows for precise delivery and positioning of balloons, stents, and other therapeutic devices within the coronary arteries.
Indications for Use
The FDA indications for this device include its use in procedures that require the delivery of interventional devices to the coronary arteries. It is intended for patients undergoing treatment for coronary artery disease, where access to the coronary vasculature is necessary.
Practical Considerations
The ACS ET Hi-Flow Enhanced Torque Coronary Guiding Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional devices used in coronary procedures. Clinicians should be familiar with catheter handling techniques to optimize performance and minimize complications.
Frequently Asked Questions
What is ACS ET Hi-Flow Enhanced Torque Coronary Guid Cath used for?
It is used to facilitate the delivery of interventional devices to the coronary arteries during procedures such as angioplasty or stent placement.
What specialties typically use this device?
Interventional cardiologists typically use this device in hospital catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring access to the coronary arteries for the delivery of interventional devices, primarily in the treatment of coronary artery disease.
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.