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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
510K
Number
K850353 ↗
Decision Date
April 10, 1985
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in interventional cardiology, particularly during procedures that require precise delivery of drugs or contrast media to the coronary arteries. It is often employed in hospital settings, such as cardiac catheterization labs, and is used for patients undergoing treatment for coronary artery disease. The device is suitable for adult patients who require targeted coronary interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in patients needing targeted delivery of therapeutic agents to the coronary arteries. It is particularly useful in conditions where precise drug delivery can improve outcomes, such as in cases of coronary artery disease.
Practical Considerations
Clinicians should consider the catheter's compatibility with other devices used during coronary interventions. Typical sizing may vary, so selecting the appropriate size for the patient's anatomy is crucial. Proper technique in threading and positioning the catheter is essential for effective use.
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.