đź“‹ FDA Reference
acs soft-tip coronary infusion catheter w sidehole
Advanced Cardiovascular Systems
Summary: The ACS Soft-Tip Coronary Infusion Catheter is a medical device used for delivering therapeutic agents directly into the coronary arteries. It is primarily used by interventional cardiologists during procedures like angioplasty.
FDA Clearance Information
Pathway
510K
Number
K875269 ↗
Decision Date
February 12, 1988
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ACS Soft-Tip Coronary Infusion Catheter was cleared through the FDA 510(k) pathway on February 12, 1988. Manufactured by Advanced Cardiovascular Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The ACS Soft-Tip Coronary Infusion Catheter is designed to infuse medications or contrast agents directly into coronary arteries. Its soft-tip design minimizes trauma to the vessel walls, making it suitable for delicate coronary interventions. The catheter's sidehole feature allows for even distribution of the infused substance, enhancing the effectiveness of the treatment.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during procedures such as percutaneous coronary interventions (PCI) and angioplasty. It is utilized in hospital settings, especially in cardiac catheterization labs, to deliver medications like thrombolytics or contrast media. The device is suitable for adult patients with coronary artery disease requiring targeted infusion therapy.
Indications for Use
The device is indicated for use in patients needing direct infusion of therapeutic agents into the coronary arteries. This includes conditions like coronary artery disease where localized delivery of medication can aid in treatment.
Practical Considerations
The catheter typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard guidewires and introducer sheaths used in coronary interventions. Clinicians should be familiar with the catheter's handling and infusion techniques to optimize its use.
Frequently Asked Questions
What is the ACS Soft-Tip Coronary Infusion Catheter used for?
It is used for delivering therapeutic agents directly 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?
The device is indicated for the infusion of therapeutic agents into coronary arteries, particularly in patients with 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.