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medtronic r gc iii coronary guiding catheter
Medtronics Interventional Vascular
Summary: The Medtronic R GC III Coronary Guiding Catheter is a device used in coronary interventions. It is primarily used to guide other devices into the coronary arteries. Key evidence findings include its efficacy in facilitating coronary procedures.
FDA Clearance Information
Pathway
510K
Number
K950179 ↗
Decision Date
July 25, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on July 25, 1995. It is manufactured by Medtronics Interventional Vascular and is classified as a Class 2 device.
What It Is
The Medtronic R GC III Coronary Guiding Catheter is designed to provide a pathway for other interventional devices into the coronary arteries. It is used in percutaneous coronary interventions to facilitate access and delivery of therapeutic devices.
Clinical Applications
Commonly used in procedures such as angioplasty and stent placement, the catheter aids in the navigation and placement of interventional devices within the coronary vasculature. It is essential in scenarios requiring precise device delivery.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published around 2025. These studies provide insights into the device's clinical performance and safety profile.
Reported Outcomes
Published studies report that the Medtronic R GC III Coronary Guiding Catheter effectively facilitates coronary interventions, improving procedural success rates. It is associated with enhanced device delivery accuracy and reduced procedure times.
Safety Profile
Reported complications include potential vascular injury and device-related thrombus formation. However, these events are relatively rare and manageable with appropriate clinical interventions.
Evidence Limitations
The evidence base is limited by the heterogeneity of study designs and small sample sizes in some studies. Further research is needed to explore long-term outcomes and comparative effectiveness with newer devices.
Frequently Asked Questions
What are the clinical indications for Medtronic R GC III Coronary Guiding Catheter?
The device is indicated for use in coronary interventions to facilitate the delivery of interventional devices into the coronary arteries.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and device delivery accuracy during coronary interventions.
What complications have been reported?
Safety data indicate potential for vascular injury and thrombus formation, though these are rare and manageable.
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.