đź“‹ FDA Reference
acs urethan coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The ACS Urethan Coronary Guiding Catheter is a medical device used in interventional cardiology for guiding other instruments into coronary arteries. It is primarily used by cardiologists during procedures such as angioplasty.
FDA Clearance Information
Pathway
510K
Number
K904884 ↗
Decision Date
January 3, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Urethan Coronary Guiding Catheter was cleared through the FDA 510k pathway on January 3, 1991, by Advanced Cardiovascular Systems. It is classified as a Class 2 device under the product code DQY.
What It Is
The ACS Urethan Coronary Guiding Catheter is a specialized tube designed to facilitate the introduction of interventional devices into the coronary arteries. It provides support and stability during procedures such as percutaneous coronary interventions (PCI). The catheter is typically made of flexible materials that allow it to navigate the vascular system with minimal trauma.
Clinical Applications
This device is commonly used in cardiac catheterization labs during procedures like angioplasty and stent placement. Interventional cardiologists use it to guide wires and other devices into the coronary arteries to treat conditions such as coronary artery disease. It is used in both elective and emergency settings, often in patients with acute coronary syndromes.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the delivery of interventional devices to the coronary arteries. It is intended for patients undergoing procedures to treat coronary artery blockages.
Practical Considerations
The ACS Urethan Coronary Guiding Catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional devices such as guidewires and balloon catheters. Clinicians should be familiar with catheter manipulation techniques to ensure successful navigation and minimize vascular trauma.
Frequently Asked Questions
What is the ACS Urethan Coronary Guiding Catheter used for?
It is used to guide interventional devices into the coronary arteries during procedures like angioplasty.
What specialties typically use this device?
Interventional cardiologists primarily use this device in cardiac catheterization labs.
What are the FDA-cleared indications?
It is indicated for use in guiding interventional devices to the coronary arteries during procedures to treat coronary artery blockages.
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.