📋 FDA Reference
Coronary Infusion Catheter W Sideholes
Advanced Cardiovascular Systems
Summary: The coronary infusion catheter with sideholes is a medical device used to deliver therapeutic agents directly into the coronary arteries. It is primarily used by interventional cardiologists during procedures such as angioplasty.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K850353 ↗
Decision Date ?
April 10, 1985
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on April 10, 1985, by Advanced Cardiovascular Systems. It is classified as a Class 2 device under product code DQY.
What It Is
The coronary infusion catheter with sideholes is designed to deliver medications or contrast agents directly into the coronary arteries. It features sideholes that allow for even distribution of the agent across the targeted area. This device is typically used in conjunction with other interventional cardiology tools to enhance the efficacy of procedures such as angioplasty or stent placement.
FDA-Cleared Indications
- Delivery of therapeutic agents into the coronary arteries during percutaneous coronary interventions.
- Delivery of contrast material into the coronary arteries for diagnostic or interventional imaging.
Clinical Applications
- Targeted coronary delivery of medication during catheter-based treatment of coronary artery disease.
- Injection of contrast material to visualize the coronary arteries during cardiac catheterization.
- Use with other percutaneous coronary intervention devices when localized infusion is needed.
Practical Considerations
- The catheter must be compatible with the guidewire, guide catheter, injection system and other devices used for the procedure.
- Available dimensions, working length, lumen size and sidehole configuration vary by model; selection should match the coronary anatomy and intended infusion.
- The catheter is advanced and positioned under fluoroscopic guidance by trained cardiovascular professionals.
- MRI safety depends on the specific catheter and whether it remains in the patient; the device labeling should be reviewed before MRI.
- Potential complications include vessel spasm, dissection, perforation, thrombosis, embolization, bleeding and reactions to the infused medication or contrast material.
Frequently Asked Questions
What is the coronary infusion catheter with sideholes used for?
It is used to deliver 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 delivery of therapeutic agents to the 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.