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usci coronary infusion catheter
C.R. Bard
Summary: The USCI Coronary Infusion Catheter by C.R. Bard is a Class 2 medical device cleared by the FDA for coronary infusion applications. Key evidence includes studies on pharmacological atrial defibrillation and synchronized coronary sinus retroperfusion.
FDA Clearance Information
Pathway
510K
Number
K891069 ↗
Decision Date
August 9, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The USCI Coronary Infusion Catheter was cleared through the FDA 510(k) pathway on August 9, 1989. It is manufactured by C.R. Bard and classified as a Class 2 device.
What It Is
The USCI Coronary Infusion Catheter is designed for the infusion of therapeutic agents into the coronary vasculature. It is used in procedures requiring precise delivery of medications to the heart.
Clinical Applications
Commonly used in scenarios such as pharmacological atrial defibrillation and coronary sinus retroperfusion, this catheter facilitates targeted drug delivery in cardiac interventions.
Evidence Summary
The literature includes five studies ranging from 1986 to 2000, covering various clinical applications such as atrial defibrillation and coronary sinus retroperfusion. Study types include case reports and clinical trials.
Reported Outcomes
Published studies report successful pharmacological atrial defibrillation and effective coronary sinus retroperfusion using the catheter. These interventions have shown potential in supporting ischemic myocardium and treating acute cardiac conditions.
Safety Profile
Reported complications include inadvertent balloon extrusion and potential risks associated with catheter insertion. Safety profiles vary depending on the specific clinical application.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of recent studies. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for USCI Coronary Infusion Catheter?
The catheter is indicated for use in coronary infusion procedures, including pharmacological atrial defibrillation and coronary sinus retroperfusion.
What outcomes have been reported in clinical studies?
Studies have reported successful atrial defibrillation and myocardial support during ischemic events using the catheter.
What complications have been reported?
Safety data indicate risks such as balloon extrusion and complications related to catheter insertion.
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.