đź“‹ FDA Reference
acs hi-torque coronary guiding catheter w soft tip
Advanced Cardiovascular Systems
Summary: The ACS Hi-Torque Coronary Guiding Catheter is a medical device used in interventional cardiology to facilitate the placement of other devices within the coronary arteries. It is primarily used by cardiologists during procedures such as angioplasty.
FDA Clearance Information
Pathway
510K
Number
K874874 ↗
Decision Date
February 18, 1988
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Hi-Torque Coronary Guiding Catheter was cleared via the FDA 510(k) pathway on February 18, 1988. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The ACS Hi-Torque Coronary Guiding Catheter is designed to provide support and guidance for the delivery of interventional devices such as balloons and stents within the coronary arteries. Its soft tip minimizes trauma to the vessel walls, enhancing patient safety. The catheter's design allows for precise navigation through the vascular system, making it an essential tool in coronary interventions.
Clinical Applications
This catheter is commonly used in procedures like percutaneous coronary interventions (PCI), where it helps in the placement of stents and balloons to treat coronary artery disease. It is typically used in hospital settings, particularly in cardiac catheterization labs, by interventional cardiologists. The device is suitable for adult patients with coronary artery blockages requiring intervention.
Indications for Use
The ACS Hi-Torque Coronary Guiding Catheter is indicated for use in patients undergoing procedures to open blocked coronary arteries. It is specifically designed to assist in the delivery of therapeutic devices to the site of a coronary lesion.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional cardiology equipment. Clinicians should be trained in catheterization techniques to ensure optimal outcomes and minimize complications.
Frequently Asked Questions
What is the ACS Hi-Torque Coronary Guiding Catheter used for?
It is used to guide and support the placement of interventional devices like stents and balloons in coronary artery procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device during coronary interventions in cardiac catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for use in procedures to open blocked coronary arteries, assisting in the delivery of therapeutic devices to coronary lesions.
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.