📋 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 ?
510(k)
Number ?
K875269 ↗
Decision Date ?
February 12, 1988
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Infusion of contrast media or therapeutic agents into the coronary arteries during percutaneous catheter procedures.
- Use in coronary interventions when targeted delivery of a medication or contrast agent is required.
Clinical Applications
- Selective infusion into coronary arteries during diagnostic cardiac catheterization.
- Delivery of contrast media during coronary angiography.
- Delivery of therapeutic agents during catheter-based coronary interventions.
- Use during percutaneous coronary intervention or angioplasty when coronary infusion is clinically indicated.
Practical Considerations
- The available catheter sizes and lengths should be matched to the patient's anatomy, the access route and the planned coronary procedure.
- The catheter is used with compatible guidewires, introducer sheaths and injection or infusion systems according to the device labeling and institutional protocols.
- Operators should advance and position the soft tip under fluoroscopic guidance and avoid excessive force, which can cause coronary dissection, perforation or other vessel injury.
- MRI safety is not established from the available FDA record; the device should be considered not evaluated for MRI unless current labeling specifically identifies it as MR Safe or MR Conditional.
- Potential complications include bleeding or hematoma at the access site, coronary spasm, thrombosis, embolization, vessel injury, arrhythmia and allergic or kidney-related reactions to contrast or infused medication.
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.