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acs soft-tip coronary infusion cath w side holes
Advanced Cardiovascular Systems
Summary: The ACS Soft-Tip Coronary Infusion Catheter with Side Holes is a medical device used for delivering therapeutic agents directly into coronary arteries. It is primarily used by interventional cardiologists in catheterization labs.
FDA Clearance Information
Pathway 510K
Number K883564 ↗
Decision Date November 3, 1988
Product Code DQY
Device Class Class 2
Evidence 0 studies
The ACS Soft-Tip Coronary Infusion Catheter with Side Holes was cleared through the FDA 510(k) pathway on November 3, 1988. It is manufactured by Advanced Cardiovascular Systems and classified as a Class II device under product code DQY.
What It Is
The ACS Soft-Tip Coronary Infusion Catheter with Side Holes is designed to facilitate the delivery of medications or contrast agents directly into the coronary arteries. It features a soft tip to minimize trauma to the vessel walls and side holes to allow for even distribution of the infused substances. This catheter is typically used during coronary interventions to enhance the efficacy of therapeutic agents.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during procedures such as percutaneous coronary interventions (PCI). It is utilized in catheterization labs to deliver medications like thrombolytics or vasodilators directly to the site of a coronary blockage. The device is suitable for adult patients undergoing coronary interventions, especially those with complex coronary artery disease.
Indications for Use
The FDA-cleared indications for this device include the delivery of therapeutic agents into coronary arteries. It is intended for patients requiring targeted delivery of medications during coronary interventions, such as those with acute coronary syndromes or chronic coronary artery disease.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guide catheters and requires careful handling to ensure proper placement and function. Clinicians should be familiar with catheterization techniques to optimize its use.
Frequently Asked Questions
What is ACS Soft-Tip Coronary Infusion Cath w Side Holes used for?
It is used to deliver therapeutic agents directly into coronary arteries during interventional cardiology procedures.
What specialties typically use this device?
Interventional cardiologists primarily use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for the delivery of therapeutic agents into coronary arteries during coronary 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.