📋 FDA Reference
Corday Coronary Sinus Infusion Catheter
Retroperfusion Systems
Summary: The Corday Coronary Sinus Infusion Catheter is used for retrograde coronary sinus perfusion in cardiac procedures. It is primarily used by cardiologists in interventional settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K865074 ↗
Decision Date ?
May 6, 1987
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Corday Coronary Sinus Infusion Catheter was cleared through the FDA 510(k) pathway on May 6, 1987. It is manufactured by Retroperfusion Systems and classified as a Class 2 device.
What It Is
The Corday Coronary Sinus Infusion Catheter is a specialized catheter designed for retrograde infusion of solutions into the coronary sinus. This technique is used to deliver therapeutic agents directly to the heart muscle, potentially improving myocardial perfusion during ischemic events. The catheter features a balloon that can be inflated to prevent backflow, ensuring targeted delivery of the infusion.
FDA-Cleared Indications
- Retrograde infusion into the coronary sinus during cardiac procedures.
- Temporary catheter-based delivery of solutions through the coronary sinus when coronary sinus perfusion is required.
Clinical Applications
- Retrograde coronary sinus perfusion during cardiac interventions.
- Delivery of an infusion solution to the myocardium through the coronary venous circulation.
- Temporary balloon occlusion of the coronary sinus to limit backflow during infusion.
Practical Considerations
- The catheter requires image-guided placement through a venous access site into the coronary sinus; the exact access route depends on the procedure and operator preference.
- Balloon inflation must be carefully controlled to reduce backflow without causing excessive pressure or injury to the coronary sinus.
- Use requires clinicians trained in coronary sinus catheterization, infusion monitoring and management of cardiac complications.
- The available sizes and infusion-system compatibility should be confirmed from the device labeling or manufacturer documentation before use.
- MRI safety is not established from the provided FDA record. Confirm the current labeling before MRI; do not assume the catheter is MR safe or MR conditional.
Related Literature
The linked study investigated the use of retrograde coronary venous contrast echocardiography in dogs to assess myocardial perfusion. It found that retrograde injections after coronary occlusion resulted in significant myocardial opacification, suggesting potential benefits in ischemic conditions. However, the study was limited to an animal model, and results may not directly translate to human patients.
Frequently Asked Questions
What is the Corday Coronary Sinus Infusion Catheter used for?
It is used for retrograde infusion of therapeutic agents into the coronary sinus to enhance myocardial perfusion.
What specialties typically use this device?
Interventional cardiologists primarily use this device during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for retrograde coronary sinus infusion to improve myocardial perfusion in ischemic conditions.
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.