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right coronary guiding catheter
Advanced Cardiovascular Systems
Summary: The right coronary guiding catheter by Advanced Cardiovascular Systems is a device used in coronary interventions. It was FDA cleared via the 510k pathway. Key evidence includes studies on its use in coronary procedures.
FDA Clearance Information
Pathway
510K
Number
K833801 ↗
Decision Date
March 12, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The right coronary guiding catheter was cleared by the FDA through the 510k pathway on March 12, 1984. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The right coronary guiding catheter is a medical device used to facilitate the delivery of interventional tools to the coronary arteries. It is primarily used in percutaneous coronary interventions to provide support and guidance for other devices.
Clinical Applications
This device is commonly used in procedures involving the right coronary artery, such as angioplasty or stent placement. It provides a pathway for other devices to reach the coronary arteries safely and effectively.
Evidence Summary
The available literature includes 10 studies, comprising case reports and various study designs, published between 1999 and 2022. These studies explore the device's application in coronary interventions.
Reported Outcomes
Published studies report successful use of the right coronary guiding catheter in facilitating coronary interventions. Outcomes include effective delivery of interventional tools and improved procedural success rates. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include potential risks associated with coronary interventions, such as vessel injury or dissection. The evidence provided does not specify detailed safety outcomes for this device.
Evidence Limitations
The evidence base is limited by a lack of large-scale randomized controlled trials specifically evaluating the right coronary guiding catheter. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for right coronary guiding catheter?
The device is indicated for use in coronary interventions, particularly involving the right coronary artery, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of coronary interventions, though specific efficacy outcomes are not detailed.
What complications have been reported?
Reported complications include risks typical of coronary interventions, such as vessel injury, but specific data for this device is limited.
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.