📋 FDA Reference
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 ?
510(k)
Number ?
K871425 ↗
Decision Date ?
May 22, 1987
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to introduce and guide interventional devices into the coronary arteries during catheter-based procedures.
- Used to provide a conduit and support for the delivery of devices used to treat coronary artery disease.
- Intended for use in percutaneous coronary interventions, including procedures involving balloon angioplasty or coronary stent delivery.
Clinical Applications
- Guiding balloon catheters to narrowed or blocked coronary arteries.
- Supporting delivery of coronary stents during percutaneous coronary intervention.
- Providing catheter support during diagnostic and interventional coronary angiography.
- Accessing coronary artery lesions in patients undergoing catheter-based treatment for coronary artery disease.
Practical Considerations
- Available catheter size, tip shape, length, and lumen dimensions should be selected according to the coronary anatomy and the interventional devices being used.
- The catheter must be compatible with the guidewire, balloon, stent, contrast injector, and other equipment used during the procedure.
- Torque should be applied carefully under fluoroscopic guidance to reduce the risk of vessel injury, catheter damage, or loss of control.
- This is a single-use catheter; it is not intended for resterilization or reuse.
- MRI safety depends on the specific catheter materials and whether the device remains in the patient. The applicable product labeling should be checked before MRI.
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.